16 Tex. Admin. Code § 118.10

Current through Reg. 49, No. 49; December 6, 2024

Section 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.

(2) 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.

(3) 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.

(4) 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 chapter.

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

(6) Certified individual--Any individual issued an individual LHR certificate by the department.

(7) Commission--The Texas Commission on Licensing and Regulation.

(8) Consulting physician--A physician who has a contract with a LHR facility.

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

(10) Customer--For purposes of this chapter, "client' is an equivalent term for "customer".

(11) Department--The Texas Department of Licensing and Regulation.

(12) Direct supervision--Direct observation by a senior LHR technician or a LHR professional of LHR procedures performed by a LHR apprentice-in-training. Direct supervision shall include the following:

(A) the physical presence of senior LHR technician or LHR professional at the LHR facility;

(B) the availability of the senior LHR technician or LHR professional 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.

(13) Executive Director--The executive director of the department.

(14) Individual LHR certificate-- An individual who has met the requirements for individual LHR certification. The term includes certificates issued by the department for a LHR professional, a senior LHR technician, a LHR technician, and a LHR apprentice-in-training.

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

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

(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.

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

(19) 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.

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

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

(22) 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.

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

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

(25) 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.

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

(27) 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, § RSA 401.510.

(28) Supervision--The physical presence of a senior LHR technician or LHR professional at the LHR facility.

16 Tex. Admin. Code § 118.10

Adopted by Texas Register, Volume 42, Number 37, September 15, 2017, TexReg 4815, eff. 11/1/2017