16 Tex. Admin. Code § 118.70 - Laser Hair Removal Devices - General and Operating Requirements

(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.

Notes

16 Tex. Admin. Code § 118.70

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