Texas Administrative Code › Title 16 - ECONOMIC REGULATION › Part 4 - TEXAS DEPARTMENT OF LICENSING AND REGULATION › Chapter 118 - LASER HAIR REMOVAL › Section 118.3 - Scope

Current through Reg. 49, No. 28; July 12, 2024
(a) Except as otherwise specifically
				provided, this chapter 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.
(b) This chapter does not apply to the
				manufacture of LHR devices.
(c) 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.
(d) Except for
				consulting physicians, this chapter does not apply to a physician or to a
				physician's employee or delegate acting under Texas Occupations Code, Chapter
				157.
(e) A certificate issued in
				accordance with this chapter only authorizes a person to perform nonablative
				cosmetic LHR. The certificate issued in accordance with this chapter 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.
(f) This chapter 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 22 TAC §
				289.301(relating to Registration and Radiation Safety Requirements for Lasers
				and Intense-Pulsed Light Devices).
(g) 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 chapter and 22 TAC §
				289.301.
(h) 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 chapter if the
				performance of laser hair removal is within the scope of that professional's
				practice as determined by the professional's licensing board.
(i) 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.
(j) Training
				programs complying with the requirements of §118.33(e), are also subject
				to certain requirements of 22 TAC § 289.226(relating to Registration of
				Radiation Machine Use and Services).
(k) 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 chapter:
(1) the requirements for a consulting
				physician specified in §118.30, shall satisfy the requirement for
				supervision by a physician specified in Title 21, CFR, §801.109;
				and
(2) the requirement for a
				consulting physician to establish protocols for a LHR facility in accordance
				with §118.30, shall satisfy the requirement for a prescription for use as
				specified in Title 21, CFR, §801.109.