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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER GREGISTRATION REGULATIONS
RULE §289.302Registration and Radiation Safety Requirements for Use of Laser Hair Removal Devices

(a) Purpose.

  (1) This section establishes requirements for radiation safety in the use of lasers or pulsed light devices for hair removal procedures. This section includes requirements for laser hair removal (LHR) facility operations, training and qualifications for persons performing LHR procedures, customer notification, consulting physicians, enforcement, penalties, and responsibilities of the registrant, laser safety officer (LSO), certified individuals, and consulting physicians.

  (2) This section establishes requirements for the registration of LHR facilities and the certification of individuals who perform or attempt to perform LHR procedures. No person may operate a LHR facility except as authorized in a certificate of LHR registration issued by the agency in accordance with the requirements of this section. No person may perform or attempt to perform LHR except as authorized in a certificate issued by the agency in accordance with this section.

  (3) This section establishes fees and fee payment requirements for certificates of LHR registration for LHR facilities and individual LHR certificates for individuals who perform or attempt to perform LHR procedures. The fees and fee payment requirements apply to applications and renewals of certificates of LHR registration and individual LHR certificates.

(b) Scope.

  (1) Except as otherwise specifically provided, this section applies to all persons who operate a location that provides LHR procedures using LHR devices and to all persons who perform or attempt to perform LHR procedures using LHR devices. This section does not apply to the manufacture of LHR devices.

  (2) A LHR device used for nonablative hair removal procedures shall meet the applicable performance standards for light-emitting products specified in Title 21, Code of Federal Regulations (CFR), §1040.10 and §1040.11.

  (3) Except for consulting physicians, this section does not apply to a physician or to a physician's employee or delegate acting under Occupations Code, Chapter 157.

  (4) A certificate issued in accordance with subsection (k) of this section only authorizes a person to perform nonablative cosmetic LHR. The certificate issued in accordance with subsection (k) of this section does not authorize an individual to diagnose, treat, or offer to treat any client for any illness, disease, injury, defect or deformity of the human body.

  (5) This section applies only to LHR devices used for nonablative hair removal. Lasers or pulsed light devices used for any other purpose shall comply with the requirements of §289.301 of this title (relating to Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices).

  (6) A person who receives, possesses, uses, owns, or acquires LHR devices prior to receiving a certificate of LHR registration is subject to the requirements of this section.

  (7) A health professional licensed under another law is not required to hold a certificate to perform laser hair removal procedures issued in accordance with this section if the performance of laser hair removal is within the scope of that professional's practice as determined by the professional's licensing board.

  (8) The qualifications for eligibility for an applicant for a senior LHR technician certificate who is a licensed health professional shall be established by the entity that issues licenses for that health profession.

  (9) Training programs complying with the requirements of subsection (j)(20) of this section are also subject to certain requirements of §289.226 of this title (relating to Registration of Radiation Machine Use and Services).

  (10) A LHR device categorized by the United States Food and Drug Administration (FDA) as a prescription device shall meet the requirements for prescription use specified in Title 21, CFR, §801.109. For purposes of this section, the requirements for a consulting physician specified in subsection (i)(13) of this section shall satisfy the requirement for supervision by a physician specified in Title 21, CFR, §801.109. For purposes of this section, the requirement for a consulting physician to establish protocols for a LHR facility in accordance with subsection (i)(13) of this section shall satisfy the requirement for a prescription for use as specified in Title 21, CFR, §801.109. A LHR device shall be purchased by or on the order of a physician, in accordance with Title 21, CFR, §801.109 and subsection (q)(2) of this section.

(c) Prohibitions.

  (1) The agency may prohibit the use of LHR devices that pose a significant threat or endanger occupational or public health and safety, in accordance with subsections (z) and (ee) of this section.

  (2) A person shall not operate a LHR facility unless the person holds a certificate of LHR registration issued by the agency in accordance with subsection (k) of this section.

  (3) An individual shall not use LHR devices to perform or attempt to perform LHR procedures unless the person holds the individual LHR certificate issued by the agency in accordance with subsection (k) of this section.

  (4) An individual shall not operate a laser hair removal device with the intent to treat an illness, disease, injury, or physical defect or deformity unless the individual is:

    (A) a physician;

    (B) acting under a physician's order; or

    (C) authorized under other law to treat the illness, disease, injury, or physical defect or deformity in that manner.

  (5) A person who violates paragraph (4) of this subsection is practicing medicine in violation of Occupations Code, Title 3, Subtitle B, and is subject to the penalties under that subtitle and under Health and Safety Code, §401.522.

  (6) A person shall not operate a LHR facility from a person's living quarters. A LHR facility shall be separated from living quarters by complete floor to ceiling partitioning and shall contain no access to living quarters.

(d) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.

  (1) Act--Texas Radiation Control Act, Health and Safety Code, Chapter 401.

  (2) Administrative penalty--Monetary penalty assessed by the agency in accordance with the Texas Radiation Control Act (Act), §401.384 and §401.522, to emphasize the need for lasting remedial action and to deter future violations.

  (3) Adverse event--Any death or serious injury, as that term is defined in Title 21, CFR, §803.3, to a client or employee of a LHR facility that is a result of use, misuse, or failure of LHR devices or LHR safety equipment.

  (4) Advertising--All representations disseminated in any manner or by any means for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of laser hair removal services.

  (5) Agency--The Department of State Health Services or its successor.

  (6) Applicant--A person seeking a certificate of LHR registration or individual LHR certificate, issued in accordance with the provisions of the Act and the requirements in this section.

  (7) Certificate of LHR registration--A form of permission given by the agency to a LHR facility applicant who has met the requirements for LHR registration certification set out in the Act and this section. For purposes of this section, "certificate of LHR registration" is an equivalent term for "facility license" as specified in Health and Safety Code, §401.510.

  (8) Certified individual--Any individual issued an individual LHR certificate by the agency in accordance with the Act and this section.

  (9) Commissioner--The commissioner of the Department of State Health Services.

  (10) Consulting physician--A physician who has a contract with a LHR facility in accordance with subsection (i)(13) of this section.

  (11) Contract--A written legal document between a consulting physician and the operator of a LHR facility.

  (12) Direct supervision--Direct observation by a senior LHR technician or a LHR professional of LHR procedures performed by a LHR apprentice-in-training. The senior LHR technician or LHR professional shall be available to give immediate assistance if required.

  (13) Director--The director of the radiation control program in accordance with the agency's jurisdiction.

  (14) Hearing--A proceeding to examine an application or other matter before the agency in order to adjudicate rights, duties, or privileges.

  (15) Informal conference--A meeting held by the agency with a person to discuss the following:

    (A) safety, safeguards, or environmental problems;

    (B) compliance with regulatory or certificate of LHR registration condition requirements;

    (C) proposed corrective measures including, but not limited to, schedules for implementation; and

    (D) enforcement options available to the agency.

  (16) Individual LHR certificate--A form of permission given by the agency to an individual applicant who has met the requirements for individual LHR certification set out in the Act and this section. The term includes certificates issued by the agency for a LHR professional, a senior LHR technician, a LHR technician, and a LHR apprentice-in-training.

  (17) Inspection--An official examination and/or observation by the agency that includes, but is not limited to, records, tests, surveys, photographs, and monitoring to determine compliance with the Act and rules, orders, requirements, and conditions of the agency.

  (18) Laser hair removal--The use of a laser or pulsed light device for nonablative hair removal procedures. For purposes of this section, "laser hair reduction" is an equivalent term.

  (19) Laser hair removal facility--A business location that provides laser hair removal.

  (20) 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.

  (21) Laser or pulsed light device--A device approved by the FDA for laser hair removal or reduction. For purposes of this section, "LHR device" is an equivalent term.

  (22) Laser safety officer (LSO)--An individual who has knowledge of and the authority and responsibility to apply appropriate laser radiation protection rules, standards, and practices, and who shall be specifically authorized on a certificate of LHR registration.

  (23) LHR--An acronym for laser hair removal.

  (24) Licensed health professional--An individual licensed in accordance with Occupations Code, Title 3.

  (25) Living quarters--Any area used as a place of abode with provisions for sleeping, cooking, and sanitation.

  (26) Mobile LHR facility--A business location self-contained within a vehicle that provides LHR procedures within the vehicle and meets all the requirements of this section.

  (27) Nonablative hair removal procedure--A hair removal procedure using a LHR device that does not remove the epidermis.

  (28) Notice of violation--A written statement prepared by the agency of one or more alleged infringements of a legally binding requirement.

  (29) Operator--The owner of a LHR facility, an agent of an owner, or an independent contractor of a LHR facility.

  (30) Order--A specific directive contained in a legal document issued by the agency.

  (31) Person--Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, local government, any other state or political subdivision or agency thereof, or any other legal entity, and any legal successor, representative, agent, or agency of the foregoing.

  (32) Physician--An individual who meets the definition in Occupations Code, Title 3, Subtitle B, Chapter 151.

  (33) Preliminary report--A document prepared by the agency containing the following:

    (A) a statement of facts on which the agency bases the conclusion that a violation has occurred;

    (B) recommendations that an administrative penalty be imposed on the person charged;

    (C) recommendations for the amount of that proposed penalty; and

    (D) a statement that the person charged has a right to a hearing on the occurrence of the violation, the amount of the penalty, or both.

  (34) Registrant--Any facility issued a certificate of LHR registration by the agency in accordance with the Act and this section. For purposes of this section, "certificate of LHR registration" is an equivalent term for "facility license" as specified in Health and Safety Code, §401.510.

Cont'd...

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