About LASER LAWS & SAFETY REGULATIONS
A Laser is a highly regulated, powerful medical device.
It's important to first know & understand the Rules, Regulations, Laws, & safety guidelines of which apply to all lasers in the US.
Among the most often asked questions in the laser industry is that of the differences between the various laser standards and classifications. In an effort to provide some clarity on the subject, the following is a very brief description of some of the Federal/National Laser Regulatory entities we'll be covering along with additional Laws according to your State:
ANSI - The American National Standards Institute (ANSI) is an organization for which expert volunteers participate on committees to set industry consensus standards in various fields. The ANSI Z136 Committee has published or has under development seven standards specific to the laser field.
The current version of the main ANSI Z136.1 Standard (Z136.1-2000) assigns lasers into one of four broad hazard Classes (1, 2, 3a, 3b and 4) depending on the potential for causing biological damage. Classification is determined by calculations based on exposure time, laser wavelength & average power for CW or repetitively-pulsed lasers & total energy per pulse for pulsed lasers.
CDRH - The Center for Devices and Radiological Health (CDRH) is a regulatory bureau within the U.S. Federal Food and Drug Administration (FDA) of the Department of Health and Human Services. CDRH has been chartered by Congress to standardize the performance safety of manufactured laser products. All laser products that have been manufactured and entered into commerce, after August 2, 1976, must comply with these regulations.
FLPPS - The regulation is known as the Federal Laser Product Performance Standard (FLPPS), and is identified as 21CFR subchapter parts 1040.10 and 1040.11. The FLPPS assigns lasers into one of four broad hazards in a manner similar to the ANSI Z136.1 (2000) Standard - Classes I, II, IIIa, IIIb and IV) depending on the potential for causing biological damage. Most often, I instruct with Class IV lasers. Class IV levels of laser radiation are considered to be an acute hazard to the skin and eyes from direct and scattered radiation. For this reason, following the Federal Laser Regulations portion of training & education, we will take a deep dive into Laser Safety & Fundamentals.
OSHA policy has been to rely on ANSI Z136.1, the generally accepted industry laser standard, and FDA/CDRH laser manufacturer requirements. IEC - The International Electrotechnical Commission (IEC) is a global organization that prepares and publishes international standards for all electrical, electronic and related technologies. The IEC document 60825-1 is the primary standard that outlines the safety of laser products. Classification is based on calculations and determined by the AEL as with the ANSI standard, but the IEC standard also incorporates viewing conditions
The FDA’s Center for Devices and Radiological Health (CDRH) and laser safety professionals recognize the American National Standards Institute (ANSI) series of Safe Use of Laser standards as an excellent means of establishing and maintaining an adequate laser safety program. Moreover, Federal and State Occupational Safety and Health Administration (OSHA) inspectors and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) use these standards as guidelines for inspections and audits, in addition to their own rules. ANSI Standard Z136.3 for Safe Use of Lasers in Health Care Facilities contains specific guidance for users of lasers. ANSI Standard Z136.1 is the primary source for more detailed information on laser safety. Both standards should be used in conjunction with device system recommendations. The FDA/CDRH database Manufacturer and User Facility Device (MAUDE) database contains reports of adverse events involving medical devices.
Federal Regulations apply to all of the United States.
Most often, I instruct with Class IV lasers. Class IV levels of laser radiation are considered to be an acute hazard to the skin and eyes from direct and scattered radiation. For this reason, following the Federal Laser Regulations & National Safety Organizations portion of training & education, we will take a deep dive into Laser Safety & Fundamentals.
In addition, States have further Laser Laws and Regulations.
Both Federal & State Laser Laws are specific to laser use, operator, license, oversight, treatment type, facility, wavelength, power, classification, and much more.
There are 28 OSHA-approved State Plans, operating state-wide occupational safety and health programs. State Plans are required to have standards and enforcement programs that are at least as effective as OSHA's and may have different or more stringent requirements.
As an example, the Laser Law detailed below applies to a particular procedure, LHR (laser hair removal) in a particular State, Texas.
As a trainer of the full scope of lasers, it's necessary that I keep many Licenses, Certifications, & continued education current.
Details per Federal & your State Laser Laws & specifics according to laser wavelength, power, classification, use, etc, will be included in your course.
WHAT'S A CLHRP?
"Laser Professionals" are NOT Laser Techs, nor are they "Professional" Laser Techs
There are Laser Techs who may rightly say they're professional [in manor/skill] Laser Techs, however, they're not Laser Professionals; which is a specific Board Certified license.
A Laser Professional is not a Laser Technician, according to Texas Law (TX Occupational Codes), and the titles are not interchangeable as this may result in the loss of either license.
A Laser Professional by any other name; such as "Laser Technician", may be thought to be skirting their responsibilities and as such, be subject to license revocation.
As a Licensed LHR Professional, you may:
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Fulfill the Texas state requirement as the registered Professional Laser Hair Removal technician for a Texas licensed laser hair removal facility.
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Perform the necessary audits for the technician or senior technician treatment upgrade log sheets in the state of Texas.
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Perform laser hair removal treatments, at a licensed laser hair removal facility in the state of Texas, without the onsite presence of either a Consulting Physician or another Professional Laser Hair Removal Technician
CLHRP LHR Laser Professional Purpose, Benefits, & Requirements
A CLHRP, or State Board Certified Laser Hair Removal Professional, in the State of Texas and other states that adhere to similar Laser Radiation Control standards, is a LHR supervisory and practice license. The CLHRP also meets the Texas Laser Hair Removal Facility License requirements for onsite supervision during facility operating hours in place of an onsite physician or licensed healthcare practitioner.
In addition, a Laser Professional Board Certification is the absolute highest attainable level LHR License! The Board Certified LHR Professional Licensee typically serves Clinical Training Specialist roles for laser manufacturers and operated on a National level often traveling to set up and train physician and their staff on their new laser devices. The CLHRP conducts laser fundamentals and other laser-related classroom/theoretical training workshops prior to hands-on/didactic practicum.
The Laser Professional may serve PRN in the absence of the physician/licensed healthcare provider as the fill-in supervisor for LHR facilities with whom they have a consulting physician's registered contract/agreement.
Most importantly, the LHR Professional is the most qualified LHR practitioner there is AND they can appease Texas Law by supervising your LHR facility and your LHR Techs whilst treating your patients/clients with the highest practice standards and earning your client's trust with exemplary service!
Why wouldn't you have a full-time on-site, Laser Professional?
In some states; such as Texas, the cost of not having a CLHRP onsite at all times will far supersede the cost of having one. States must see a sizable revenue on their regulatory services, inspection fines, etc, as this must be greater than their cost for the State employees including inspectors who enforce the regulatory laws.
Did you know that every sanction, inspection report fine, etc is publicly posted on every Texas agency's website and emailed out to all Texas license holders? That's right, check it out on TDLR's, DSHS's, and other State websites. That sounds like there'd be no coming back from that. Texas doesn't take kindly to any practice that could remotely appear to be skirting its Law. Don't find your business or license holders on the Texas-size wall of shame!
It is a legal requirement that all facilities where laser hair removal is offered have a State Board Certified, Licensed Laser Professional (CLHRP) on site during business hours of operation. regardless whether there are laser procedures taking place at the time or not.
Further, all Laser Technicians (Laser Apprentice Technicians, Laser Technicians, and Laser Senior Technicians) are required to be supervised by the Laser Professional (CLHRP) or Consulting Physician.
A CLHRP does not require any supervision when operating a laser during laser hair removal.
A CLHRP must supervise and log a Laser Technician's (Laser Apprentice Technician, Laser Technician "Laser Tech", and/or Laser Sr. Technician) application forms for their Laser Hair Removal License.
Laser Laws differ from State to State. Texas Department of Licensing and Regulations,
Texas Department of State Health Services, and the Texas Regulations for Radiation Control Program under DSHS are all governing bodies of Laser Law in Texas Occupational Codes (TOC) under Texas Law.
TOC Law is addition to and is superseded by all Federal Laws.
INSPECTIONS
Inspectors...inspect. That's what they do...it's all they do. And they certainly do not make an appointment.
Texas Administrative Code
Inspections shall be performed during the normal operating hours of the establishments.
The Department may conduct inspections under the Act and this chapter without advance notice. INSPECTIONS ARE NOT SCHEDULED. The Department Inspector will contact the establishment/facility owner, manager, or their representative upon arrival, and before proceeding with the inspection.
"establishments must be inspected in accordance with Texas Occupations Code, Chapter 51, and the inspection rules under 16 Texas Administrative Code, Chapter 60, Subchapter H."
"The establishment or school owner, manager, employee, contractor, or their representative must cooperate with the inspector or investigator in the performance of the inspection or investigation.
Source Note: The provisions of this §83.50 adopted to be effective January 1, 2023, 47 TexReg 8640"
Who Can Own a Laser Hair Removal Clinic in Texas?
Who can own a laser hair removal business?
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Anyone can own and operate a laser hair removal facility, so long as such person holds a license to operate the facility and the facility has a written contract with a consulting physician. A separate license is required for each facility.
Each laser hair removal clinic must be registered separately and follow all applicable rules and regulations.
Who Can Perform Laser Hair Removal Services?
When all applicable requirements are met, physicians and their delegates, or persons licensed by the Texas Department of Licensing & Regulation (TDLR), may perform laser hair removal in Texas.
Within a medical practice, including a medspa, a physician may delegate to a qualified and properly trained person acting under the physician’s supervision any medical act, including laser hair removal, so long as certain conditions are met. In addition, all procedures must be:
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Performed after the patient is evaluated and diagnosed by a physician, physician assistant (PA), or advanced practice registered nurses (APRN);
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While a PA or APRN is onsite, or the delegating physician is available for emergency consultation; and
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The procedures are timely co-signed by the supervising physician.
Alternately, within a licensed laser hair removal facility, procedures are performed by persons holding a certificate or license issued by the Texas Department of Licensing and Registration and/or the Department of State Health Services.
The three levels of laser technician certification for laser hair removal licensure include:
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Apprentice-in-Training
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Technician
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Senior Technician
The highest level of laser practitioner certification for laser hair removal license is:
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Professional
A laser hair removal facility must have a licensed, Board certified Professional or healthcare practitioner, acting within their scope of practice, present to supervise the procedures performed by an apprentice, technician, or senior technician at the facility during the facility’s operating hours.
In addition, the facility must have a written contract with a consulting physician to:
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Establish protocols for the services provided at the facility; and
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Audit the facility’s protocols and operations.
The consulting physician, or a designated backup physician, must be available to the facility for emergency consultation and to any patient in need of an emergency appointment. A certified Professional acting under the protocols the Professional establishes with a consulting physician may perform laser hair removal procedures without supervision.
Can an esthetician do laser hair removal in Texas? An esthetician license does not authorize estheticians to use lasers, including lasers for laser hair removal. Under certain limited circumstances, an esthetician may perform laser hair removal procedures under a physician’s delegation and supervision where the physician is practicing medicine.
For any questions about laser hair removal in a medspa or physician’s practice, speak with a Texas healthcare lawyer.
Where Can Laser Hair Removal Be Offered?
Laser hair removal can be offered at a physician’s sole practice where the physician is onsite at all times (i.e., a doctor’s office, hospital, or med spa) – or at a licensed laser hair removal facility where a LHR Professional (CLHRP) is onsite at all times. A physician's practice is not required to register as a laser hair removal facility unless that is the only service it provides.
Start a Laser Hair Removal Business With Confidence
Starting a laser hair removal business in Texas requires careful compliance with the licensing rules and other Texas regulations, and violating Texas law can be costly for new and existing practices. Texas has more laser regulatory bodies than any other US State. A firm understanding of the many entities and what oversee and how many overlap regarding laser devices, laser practitioners, and laser radiation-related law is absolutely required to be and remain in compliance. Texas Law is very unique and complex. Texas laser regulatory bodies are well know for taking swift action against anyone or business ignorant of Texas Law. It's stated under TX Regulations that ignorance is equal to intention when considering compliance and Texas Law.
Texas Administrative Code (TAC)
TITLE 16 ECONOMIC REGULATION
PART 4 TEXAS DEPARTMENT OF LICENSING AND REGULATION
CHAPTER 118 LASER HAIR REMOVAL
RULE §118.70 Laser Hair Removal Devices--General and Operating Requirements
a LHR facility shall have a LHR Professional (or a licensed health professional [if such practice is within the scope of practitioner's license]) present to provide supervision of the LHR procedures performed at the facility during the facility's operating hours.
Each LHR device shall incorporate a key-actuated or computer-actuated master control. The key shall be removable and the LHR device shall not be operable when the key is removed.
When the LHR device is not being prepared for operation or is unattended, the controlled area shall be secured to prevent unauthorized access. (Doors must remain closed!)
Each client shall be provided with a written statement outlining the relevant risks associated with LHR procedures, including a warning that failure to use the eye protection provided to the client by the LHR facility may result in damage to the eyes.
Each certified individual shall display the certificate of LHR registration issued in accordance with this chapter in an open public area of the LHR facility. Copies of an individual's certification document may be made for display in multiple facilities.
A warning sign shall be posted in a conspicuous location that is readily visible to a person entering the LHR facility. The warning sign shall meet the following requirements:
(1) be of a size with dimensions at least 8 and 1/2 inches by 11 inches;
(2) contain wording with a font size no smaller than size 26;
(3) contain at least the following wording:
(A) Laser hair removal devices emit electromagnetic radiation that is considered to be an acute hazard to the skin and eyes from direct and scattered radiation. Laser hair removal procedures provide no medical benefit and may result in adverse effects.
(B) To make a complaint, contact the Texas Department of Licensing and Regulation, Laser Hair Removal Program at P.O. Box 12157, Austin, Texas 78711, (512) 539-5600, or www.tdlr.texas.gov.
(r) The LHR controlled area shall be conspicuously posted with LHR controlled area signs or labels as designated by the following:
(1) Title 21, CFR, §1040.10;
(2) ANSI Z136.1-2000, Safe Use of Lasers; and
(3) IEC standards 60825-1 and 60601-2-22.
(s) Records shall be made of each audit conducted. The records shall be maintained in accordance this chapter. The records shall include, but not be limited to, the following:
(1) name of the LHR Professional;
(2) name(s) of the individual(s) being audited; and
(3) date of the procedure.
(t) Records shall be made of each LHR procedure and maintained in accordance with this chapter for inspection by the Agency. Each record shall include, but not be limited to, the following:
(1) client identification;
(2) date of the LHR procedure;
(3) indication that the client was given the notification;
(4) name of the individual performing the LHR procedure;
(5) type of individual LHR certificate possessed by the individual performing the LHR procedure;
(6) name of the LHR Professional providing direct supervision, or senior LHR technician if applicable; and
(7) manufacturer, model number, and serial number of the LHR device and the settings used to perform the procedure.
Source Note: The provisions of this §118.70 adopted to be effective November 1, 2017, 42 TexReg 4815
RULE §118.10 Definitions
The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.
(1) Act--Texas Radiation Control Act, Health and Safety Code, Chapter 401.
(7) Commission--The Texas Commission on Licensing and Regulation.
(8) Consulting physician--A physician who has a contract with a LHR facility.
(11) Department--The Texas Department of Licensing and Regulation.
(12) Direct supervision--Direct observation by a LHR Professional of LHR procedures performed by a senior LHR technician, technician apprentice-in-training. Direct supervision shall include the following:
(A) the physical presence at the LHR facility;
(B) the availability of the LHR Professional; or senior LHR technician in some cases, to give immediate assistance if required; and
(C) the direct observation by the senior LHR technician or LHR Professional of LHR procedures performed by a LHR apprentice-in-training.
(16) Laser hair removal facility--A business location that provides laser hair removal (regardless of any other/additional services).
(17) Laser hair removal procedure--The removal of hair from one of the four body areas specified below, conducted during the same or separate appointment. Each area is considered one procedure, regardless of how many individual body parts are treated within that area:
(A) head and neck;
(B) upper extremities, to include hands, arms (including armpits), and shoulders;
(C) torso, to include front and back (including pelvic region and buttocks); or
(D) lower extremities, to include legs and feet.
Licensed health professional--An individual licensed in accordance with Occupations Code, Title 3.
Operator--The owner of a LHR facility, an agent of an owner, or an independent contractor of a LHR facility.
Registrant--Any facility issued a certificate of LHR registration by the department. For purposes of this chapter, "certificate of LHR registration" is an equivalent term for "facility license" as specified in Health and Safety Code, §401.510.
Supervision--The physical presence of LHR Professional or senior LHR technician at the LHR facility.
Source Note: The provisions of this §118.10 adopted to be effective November 1, 2017, 42 TexReg 4815
RULE §118.33 Laser Hair Removal Individual Certificate--Requirements and Application
"An applicant for a senior LHR technician certificate shall meet the following requirements:
(1) meet the requirements for a LHR technician certificate in accordance with this chapter; and
(2) have directly supervised at least 100 LHR procedures within 12 months, as audited by a LHR Professional. An individual shall not supervise LHR procedures without audit by a LHR Professional until:
(A) 100 LHR procedures within 12 months have been directly supervised, as audited by a LHR Professional; and
(B) an individual senior LHR technician certificate has been issued by the department in accordance with this chapter."
An applicant for a LHR technician certificate shall meet the following requirements:
(A) meet the requirements for a LHR apprentice-in-training certificate in accordance with this chapter; and
(B) have performed at least 100 LHR procedures within 12 months under the direct supervision of a LHR Professional...
(2) An individual shall not perform LHR procedures unsupervised until:
(A) 100 LHR procedures within 12 months have been performed under the direct supervision of a LHR Professional...
RULE §118.34 Laser Hair Removal Professionals and Senior Laser Hair Removal Technicians--Auditing and Supervision Requirements
(a) A physician or other licensed health professional shall not perform the auditing activities of a LHR Professional in accordance with §118.33*
(b) A physician or other licensed health professional shall not perform the direct supervision activities of a LHR Professional* *((c), unless that individual meets the requirements for a LHR Professional specified in §118.33(b).)
(c) A LHR Professional shall audit and ensure that there was direct supervision of the 100 LHR procedures performed by a LHR technician while obtaining the requirements of §118.33(c)
Source Note: The provisions of this §118.34 adopted to be effective November 1, 2017, 42 TexReg 4815
RULE §118.91 Enforcement Authority
RULE §118.30 Laser Hair Removal Facility Certificate--Requirements and Application
"(a) A separate LHR application shall be submitted for each LHR facility.
(b) A separate certificate of LHR registration is required for each LHR facility.
(c) A certificate of LHR registration for a LHR facility is not required for the following:
(1) a facility owned or operated by a physician for the [physician's primary] practice of medicine;
(2) a licensed hospital; or
(3) a clinic owned or operated by a licensed hospital.
(d) A certificate of LHR registration is required for a facility owned or operated by a physician that performs only LHR procedures.
(e) A certificate of laser registration issued in accordance with 22 TAC §289.301 may be required for the entities specified in subsection (c) that own, possess, or use lasers for purposes other than LHR.
(f) An applicant for a facility certificate of LHR registration shall complete a department-approved application which must include:
(1) a qualified LSO designated on each application form pursuant to §118.32;
(2) a qualified LHR professional designated on each application form;
Source Note: The provisions of this §118.30 adopted to be effective November 1, 2017, 42 TexReg 4815"
RULE §118.31 Laser Hair Removal Facility--Responsibilities
"(a) The LHR facility registrant must notify the department in writing of any changes that would render the information contained in the application for LHR registration or the certificate of LHR registration inaccurate.
(b) Notification is required within thirty (30) days of the following:
(1) change in business name of the LHR facility;
(2) change in physical location of the LHR facility;
(3) change in street address where LHR devices will be used;
(4) change in LSO;
(5) loss or change of the LHR facility's LHR Professional; or
(6) loss or change of the LHR facility's consulting physician."
Additional Links and Resources
More on Federal Governing Bodies or Departments Regarding/Related to Laser Law:
CDRH - Center for Devices and Radiological Health - A program within the Food and Drug Administration that addresses the elimination of unnecessary human exposure to radiation emitted from electronic products. Most medical devices subject to the FDA's oversight are regulated by the Center for Devices and Radiological Health.
CRCPD - Conference of Radiation Control Program Directors - A nonprofit professional organization whose primary membership is made up of radiation professionals in state and local government who regulate the use of radiation sources. Other members include individuals with an interest in radiation protection.
DHHS- Department of Health and Human Services - https://www.hhs.gov/
DOE- United States Department of Energy
EPA- United States Environmental Agency - Radiation Protection
HPS - Health Physics Society -- An international professional scientific organization dedicated to promoting the practice of radiation safety.
Medical Radiologic Technologists-- Radiation Control does not register or certify Medical Radiologic Technologists (MRT) nor do we issue Continuing Education Credits.
NIST - National Institute of Standards and Technology -- NIST provides a list of service organizations (labortories) that are accredited to process personnel dosimeters used to monitor individual occupational exposure to ionizing radiation. Directory of accredited laboratories for ionizing radiation dosimetry.
NRC - United States Nuclear Regulatory Commission.
CDRH Health of Women Program - CDRHHealthofWomen@fda.hhs.gov.
FDA Voices "The FDA's Critical Focus on Women's Health"
The Radiation Information Network- This site contains information about Radiation and the professions of Radiation Protection. Health Physics Program and Student Chapter of the Health Physics Society.
Radiation Registration Biennial Fees
Radioactive Material License Biennial Fees
EPA WIPP Program Page -- Federal Regulatory Agency for radioactive waste disposal at WIPP
More Regarding/Related to Texas Laser Law:
RC - Railroad Commission of Texas -- The RRC regulates the disposal of O&G NORM (Naturally Occurring Radioactive Material).
Medical Physicists -- This link will direct you to the Texas Department of State Health Services (DSHS), Professional Medical Physicist web site where you will find a list of Professional Medical Physicists as well as a list of Temporary Professional Medical Physicists.
Southern States Energy Board -- The Board's mission is to enhance economic development and the quality of life in the South through innovations in energy and environmental programs and technologies.
STCHPS - South Texas Chapter Health Physics Society -- The South Texas Chapter of the Health Physics Society is a professional society that was organized and chartered in 1964.
State Radiation Control Programs. -- An interactive map that allows you to look up other state's radiation control programs.
Texas Groundwater Protection Committee -- A committee that strives to identify areas where new or existing groundwater programs could be enhanced, as well as improve coordination among agencies involved in groundwater activities.
TCEQ - Texas Commission on Environmental Quality (formerly the Texas Natural Resource Conservation Commission or TNRCC). -- The Texas Department of Health and TCEQ have a Memorandum of Understanding (PDF) stating the responsibilities and primary jurisdiction of each agency regarding the disposal of radioactive substances.
TRAB - Texas Radiation Advisory Board -- The TRAB members are the state's advisors on all radiation issues.
WIPP -- Waste Isolation Pilot Plant, DOE Carlsbad Field Office - Facility Operations
Environment Department(NMED) WIPP Information Page - State Regulatory Agency for mixed waste disposal at WIPP
Additional Governing Bodies or Departments Regarding Texas Laser Law:
Texas Administrative Code
TITLE 25 HEALTH SERVICES
PART 1 DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289 RADIATION CONTROL
SUBCHAPTER G REGISTRATION REGULATIONS
RULE §289.301 Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices
Texas Laws - Health and Safety Code
Texas Laws and Statutes Governing Radiation Control
Statute Chapter 401; Title Radioactive Materials and Other Sources of Radiation
Sec. 401.015. Texas RADIATION ADVISORY BOARD (TRAB)- Members appointed by the Governor
TRAB reviews and evaluates state radiation policies, programs, and proposed rules. The Board also makes recommendations and provides technical advice that may be required on matters relating to development, use, and regulation of sources of radiation.
Texas Administrative Code (TAC)
TITLE 16 ECONOMIC REGULATION
PART 4 TEXAS DEPARTMENT OF LICENSING AND REGULATION
CHAPTER 118 LASER HAIR REMOVAL
RULE §118.70 Laser Hair Removal Devices--General and Operating Requirements
"DON'T MESS WITH TEXAS!"
Texas State slogan is prominently shown on road signs on major highways, television, radio and in print advertisements. TX Dept. of Transportation coined the famous phrase long ago as an anti-littering campaign.
However, upon arrival, visitors are greeted with "Welcome to Texas!" signs immediately followed with endless signs throughout our State reading, "Don't mess with Texas!" as a fair warning...and they're not kidding. Texas has more laser practitioner and laser radiation-related oversight and regulatory entities than any other state in the United States! All TX State Departments have a reputation of creating, upholding, and enforcing strict laser-related standards; which is necessary for the safety and well-being of Texans.
"Always verify the Laser Hair Removal Facility, Laser Technician, and Laser Professional (CLHRP) licenses to ensure it is current and reflects their title BEFORE anyone fires a Laser!"
https://www.tdlr.texas.gov/LicenseSearch/LicenseSearch.asp
Depending upon License type, the above search may take you to an external data search; such as in the case of laser licenses.
TDLR search will take you to DSHS where you select to search a license there.
LICENSING & REGULATIONS
LHR PROFESSIONAL RESPONSIBILITIES
The Law - Health and Safety Code
Sec. 401.517. Operational Requirements
(a) A laser hair removal facility shall have a licensed laser hair removal professional or a licensed health professional described by Section 401.504(c) present to supervise the laser hair removal procedures performed at the facility during the facility's operating hours.
(b) A laser hair removal facility may continue to perform laser hair removal procedures after the facility's certified laser hair removal professional leaves the facility if a senior laser hair removal technician is present to perform or supervise each procedure. Not later than the 45th day after the date the facility's certified laser hair removal professional leaves the facility:
(1) the facility's senior laser hair removal technician must become certified as a laser hair removal professional under Section 401.505; or
(2) the facility must hire a new certified laser hair removal professional.
Added by Acts 2009, 81st Leg., R.S., Ch. 303 (H.B. 449), Sec. 1, eff. September 1, 2010.
Laser Hair Removal Licenses
Sec. 401.505. Certified Laser Hair Removal Professional
(a) An applicant for a laser hair removal professional certificate must:
(1) be certified by a recognized certifying agency, including the Society for Clinical and Medical Hair Removal or another certification entity approved by the department;
(2) meet the requirements for a senior laser hair removal technician certificate under Section 401.506; and
(3) pass an examination required by the department.
(b) A certified laser hair removal professional acting under the protocol established with a consulting physician may perform laser hair removal without supervision.
Added by Acts 2009, 81st Leg., R.S., Ch. 303 (H.B. 449), Sec. 1, eff. September 1, 2009.
Amended by Acts 2015, 84th Leg., R.S., Ch. 838 (S.B. 202), Sec. 1.229, eff. September 1, 2017.
Sec. 401.506. Senior Laser Hair Removal Technician
(a) an applicant for a senior laser hair removal technician certificate must:
(1) meet the requirements for a laser hair removal technician certificate under Section 401.507; and
(2) have supervised at least 100 laser hair removal procedures, as audited by a certified laser hair removal professional.
Sec. 401.507. Laser Hair Removal Technician
An applicant for a laser hair removal technician certificate must:
(1) meet the requirements for a laser hair removal apprentice-in-training certificate under Section 401.508; and
(2) have performed at least 100 laser hair removal procedures under the direct supervision of a certified laser hair removal professional or a senior laser hair removal technician if a Laser Hair Removal Professional is onsite at Laser Facility.
Sec. 401.508. Laser Hair Removal Apprentice-In-Training
(a) An applicant for a laser hair removal apprentice-in-training certificate must have at least 24 hours of training in safety, laser physics, skin typing, skin reactions, treatment protocols, burns, eye protection, emergencies, and post treatment protocols.
(b) A laser hair removal apprentice-in-training must work directly under the supervision of a certified laser hair removal professional or a senior laser hair removal technician if a Laser Hair Removal Professional is onsite at Laser Facility.
Sec. 401.501. Definitions
(1) "Commission" means the Texas Commission of Licensing and Regulation.
(1-a) "Department" means the Texas Department of Licensing and Regulation.
(2) "Executive director" means the executive director of the department.
(3) "Laser hair removal" means the use of a laser or pulsed light device for nonablative hair removal procedures.
(4) "Laser hair removal facility" means a business location that provides laser hair removal.
(5) "Laser or pulsed light device" means a device approved by the department and the United States Food and Drug Administration for laser hair removal.
(6) "Nonablative hair removal procedure" means a hair removal procedure using a laser or pulsed light device that does not remove the epidermis.
(7) "Operator" means the owner of a laser hair removal facility, an agent of an owner, or an independent contractor of a laser hair removal facility.
Added by Acts 2009, 81st Leg., R.S., Ch. 303 (H.B. 449), Sec. 1, eff. September 1, 2009.
Amended by Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(74), eff. April 2, 2015.
Amended by Acts 2015, 84th Leg., R.S., Ch. 838 (S.B. 202), Sec. 1.225, eff. September 1, 2017.
Laser Law & Applicable Regulatory Changes
source: TDLR, LASER HAIR REMOVAL LAW direct weblink: https://www.tdlr.texas.gov/las/laslaw.htm LASER HAIR REMOVAL Health and Safety Code Subchapter M. Laser Hair Removal Administered by the Texas Department of Licensing and Regulation (Effective September 1, 2019)
source: TDLR, LASER HAIR REMOVAL ADMINISTRATIVE RULES direct weblink: https:// www.tdlr.texas.gov/las/lasrules.htm LASER HAIR REMOVAL Administrative Rules of the Texas Department of Licensing and Regulation 16 Texas Administrative Code, Chapter 118 (Effective November 1, 2017)
source: TDLR, GUIDANCE ON LASER DEVICES direct weblink: https://www.tdlr.texas.gov/las/ lasdevices.htm
source: DSHS RULE CROSS-REFERENCE CHART (PDF) weblink: https://www.tdlr.texas.gov/las/pdf/ LAS-rule-cross-reference-chart.pdf
source: TDLR, TDLR ENABLING LAW direct weblink: https://www.tdlr.texas.gov/enabling.htm
source: TDLR, TDLR PROCEDURAL RULES direct weblink: https://www.tdlr.texas.gov/procrules.htm
source: DSHS Laser and Laser Device Services Registration - Radiation Control Program https:// www.dshs.state.tx.us/radiation/lasers/
source: DSHS - Registration https://www.dshs.state.tx.us/WorkArea/linkit.aspx? LinkIdentifier=id&ItemID=8589943099
source: DSHS Applications & Forms https://www.dshs.state.tx.us/WorkArea/linkit.aspx? LinkIdentifier=id&ItemID=8590004508
source: DSHS Laws & Rules https://www.dshs.state.tx.us/radiation/lasers/#
source: DSHS Biennial Fees https://www.dshs.state.tx.us/radiation/lasers/#
source: DSHS Enforcement Actions https://www.dshs.state.tx.us/WorkArea/linkit.aspx? LinkIdentifier=id&ItemID=4484
source: DSHS Radiation Fees FAQs https://www.dshs.state.tx.us/WorkArea/linkit.aspx? LinkIdentifier=id&ItemID=8590004489
source: DSHS Open Records https://www.dshs.state.tx.us/WorkArea/linkit.aspx? LinkIdentifier=id&ItemID=4535
NUYU & SAFETY
Safety & Efficacy
Two factors of which there's no option otherwise: Safety and Efficacy. Your patients expect this much. You must deliver on your promise. Anything less than the safest and most effective treatment will instantly lose your patients' trust, likely injure your patient and the treatment provider, kill your business, ruin your reputation, cost you more than the price of a few devices, and potentially, your licenses. Nothing can replace the tried and true experience and knowledge an 18 year Board Certified, Licensed Laser and Aesthetic Professional brings. NuYu Services is your BioMedical Engineering, Laser and Energy-Based Device Training, Aesthetic Education go-to. Don't delay, contact NuYu today!
SAFETY/COMPLIANCE
Educator, Assessor, Radiation (Ionizing/Non-Ionizing) Safety, Principals, Protocols, & Compliance Officer
Laser Safety Officer (LSO)
Permitting, Assessment, Field Sample Collection, Documentation, Quality Control/Quality Assurance Practice
Inspection Preparation
Federal Privacy Protection - Basic Federal HIPAA Certificate, CLS
Federal Privacy Protection - PHI SPI HIPAA EXPAND TX HB 300 Certificate, CLS
NHZ Inspection
OSHA
FEMA Emergency Management Institute Federal Certifications
Reporting AR/AE Adverse Responses / Adverse Effects
Medical Device Reporting (MDR)
Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions.
Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.
The FDA reviews all medical device reports (MDRs) received. The FDA's analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. For example, in certain MDRs, the text of the report may include the word "death" or a related term. However, the MDR would not, and should not, be classified as death unless the reporter believes the patient's cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.
In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.
Mandatory Medical Device Reporting Requirements
The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a serious injury or death. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Device User Facilities: A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.
A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under the FDA's Safety Information and Adverse Event Reporting Program.
Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See "Medical Device Reporting for User Facilities," a guidance document issued by the FDA.
How to Report a Medical Device Problem
Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).
Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):
Find information and instructions for mandatory device reporting at:
-
Reporting Medical Device Adverse Events for Manufacturers, Importers and Device User Facilities
-
Instructions on Voluntary Malfunction Summary Reporting Program
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FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB)
For Questions about Medical Device Reporting, including interpretation of MDR policy:
- Call: (301) 796-6670
- Email: MDRPolicy@fda.hhs.gov
Voluntary MedWatch Reporting for Patients, Health Professionals and Consumers (Form FDA 3500):
Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to the FDA through the MedWatch program in one of the following ways:
- Complete the MedWatch Online Reporting Form
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
To Report an Emergency
If you have identified a public health emergency, you may use the following contact information to alert the FDA:
FDA Office of Crisis Management, Emergency Operations Center
- Voice (24hr/day) phone: 866-300-4374 or 301-796-8240
- FAX: 301-847-8543
Visit Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for specifics on requirements and associated processes.
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