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RULE §118.3Scope

(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.

(l) A LHR device shall be purchased by or on the order of a physician, in accordance with Title 21, CFR, §801.109 and §118.71.

Source Note: The provisions of this §118.3 adopted to be effective November 1, 2017, 42 TexReg 4815

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