| (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.
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