| (a) No person shall make, sell, lease, transfer, or
lend laser hair removal devices unless such devices, when properly
placed in operation and use, meet the applicable requirements of this
22 TAC §289.301.
(b) A LHR device used in a LHR facility shall comply
with all applicable federal and state laws and regulations.
(c) A person who adulterates or misbrands a LHR device
under Health and Safety Code, §431.111 or §431.112 violates
Health and Safety Code, Chapter 431. The Department of State Health
Services - Radiation Control Program may investigate a person accused
of adulterating or misbranding a LHR device.
(d) A LHR device used by a LHR facility may be purchased
either by a physician (such as the consulting physician or other designated
physician for emergencies) or by a LHR facility pursuant to a written
prescription or other order of a licensed physician in Texas.
(e) A prescription or other order from a licensed physician
for the purchase of a LHR device must include at a minimum:
(1) the date of the order's issue;
(2) the name and quantity of the LHR device(s) authorized
to be purchased;
(3) the name, address, and telephone number of the
registered LHR facility authorized to purchase and own the laser;
(4) the intended use of the device is limited to nonablative
laser hair removal;
(5) the name, address, and telephone number of the
physician at the physician's usual place of business, legibly printed
or stamped;
(6) a statement that the prescription is valid up to
twelve (12) months from the date of issue; and
(7) the signature of the authorizing physician.
(f) A LHR device shall not be used for LHR procedures
unless:
(1) the LHR device is approved for laser hair removal
or reduction by the FDA for that purpose; and
(2) the LHR device is operated only at the settings
expected to safely remove hair, in accordance with the manufacturer's
instructions and protocols established by the consulting physician
in accordance with this chapter and other applicable law regulating
devices.
(g) Except as provided by subsection (h), a LHR facility
shall have a LHR professional or a licensed health professional present
to provide supervision of the LHR procedures performed at the facility
during the facility's operating hours.
(h) A LHR facility may continue to perform LHR procedures
after the facility's LHR professional leaves the facility or is continuously
absent for up to forty-four (44) days if a senior LHR technician is
present to perform or directly supervise each procedure. Not later
than the 45th day after the date the facility's LHR professional leaves
or is continuously absent from the facility:
(1) the facility's senior LHR technician shall become
certified as a LHR professional in accordance with this chapter; or
(2) the facility shall hire a new LHR professional.
(i) Individuals operating each laser presently being
used or listed on the current inventory, shall be provided with written
instructions for safe use, including clear warnings and precautions
to be taken when using the LHR device.
(j) Each individual receiving the instructions shall
document that they have read and understand the instructions. The
instructions and the documentation that each individual has read and
understands the instructions shall be maintained in accordance with
this chapter.
(k) A controlled area shall be established within a
room in which LHR devices are used and the LHR devices should be secure
from unauthorized removal.
(l) Each LHR device shall incorporate a key-actuated
or computer-actuated master control. The key shall be removable and
the LHR device shall not be operable when the key is removed. When
the LHR device is not being prepared for operation or is unattended,
the controlled area shall be secured to prevent unauthorized access.
(m) Protective eyewear shall be worn by all individuals
using a LHR device or all individual present, including clients, in
the room where a LHR device is being used. Protective eyewear devices
shall meet the following requirements:
(1) provide a comfortable and appropriate fit all around
the area of the eye;
(2) be in proper condition to ensure the optical filter(s)
and frame provide the required optical density or greater at the desired
wavelengths, and retain all protective properties during its use;
(3) be suitable for the specific wavelength of the
laser and be of optical density adequate for the energy involved;
(4) have the optical density or densities and associated
wavelength(s) permanently labeled on the filters or eyewear; and
(5) be examined, at intervals not to exceed twelve
(12) months, to ensure the reliability of the protective filters and
integrity of the protective filter frames. Unreliable eyewear shall
be discarded. Documentation of the examination shall be made and maintained
in accordance with this chapter.
(n) Each client shall be provided with a written statement
outlining the relevant risks associated with LHR procedures, including
a warning that failure to use the eye protection provided to the client
by the LHR facility may result in damage to the eyes.
(o) Compliance with the written statement requirement
specified in subsection (n), does not affect the liability of the
LHR facility operator or a manufacturer of a LHR device.
(p) Each certified individual shall display the certificate
of LHR registration issued in accordance with this chapter in an open
public area of the LHR facility. Copies of an individual's certification
document may be made for display in multiple facilities.
(q) A warning sign shall be posted in a conspicuous
location that is readily visible to a person entering the LHR facility.
The warning sign shall meet the following requirements:
(1) be of a size with dimensions at least 8 and 1/2
inches by 11 inches;
(2) contain wording with a font size no smaller than
size 26;
(3) contain at least the following wording:
(A) Laser hair removal devices emit electromagnetic
radiation that is considered to be an acute hazard to the skin and
eyes from direct and scattered radiation. Laser hair removal procedures
provide no medical benefit and may result in adverse effects.
(B) To make a complaint, contact the Texas Department
of Licensing and Regulation, Laser Hair Removal Program at P.O. Box
12157, Austin, Texas 78711, (512) 539-5600, or www.tdlr.texas.gov.
(r) The LHR controlled area shall be conspicuously
posted with signs or labels as designated by the following:
(1) Title 21, CFR, §1040.10;
(2) ANSI Z136.1-2000, Safe Use of Lasers; and
(3) IEC standards 60825-1 and 60601-2-22.
(s) Records shall be made of each audit conducted.
The records shall be maintained in accordance this chapter. The records
shall include, but not be limited to, the following:
(1) name of the LHR professional;
(2) name(s) of the individual(s) being audited; and
(3) date of the procedure.
(t) Records shall be made of each LHR procedure and
maintained in accordance with this chapter for inspection by the agency.
Each record shall include, but not be limited to, the following:
(1) client identification;
(2) date of the LHR procedure;
(3) indication that the client was given the notification;
(4) name of the individual performing the LHR procedure;
(5) type of individual LHR certificate possessed by
the individual performing the LHR procedure;
(6) name of the senior LHR technician or LHR professional
providing direct supervision, if applicable; and
(7) manufacturer, model number, and serial number of
the LHR device and the settings used to perform the procedure.
(u) Each person registered by the department for use
of LHR devices in accordance with this chapter shall confine use and
possession of the LHR devices to the location and purpose authorized
in the facility certificate of LHR registration. If a LHR facility
operator owns multiple LHR facilities, the operator may transfer a
LHR device from facility to facility that the operator owns if each
facility is registered.
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