- (a) An LHR device used in an LHR facility must follow all applicable federal and state laws and regulations.
- (b) An LHR device used by an LHR facility must be purchased either by a physician (such as the consulting physician or alternate consulting physician) or by an LHR facility pursuant to a written prescription or other order of a licensed physician in Texas.
(c) A prescription or other order from a licensed physician for the purchase of an LHR device must include at a minimum:
- (1) the date the physician issued the order;
- (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 12 months from the date of issue; and
- (7) the signature of the authorizing physician.
(d) An LHR device must 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.
- (e) Individuals operating each laser presently being used or listed on the current inventory, must be provided with written instructions for safe use, including clear warnings and precautions to be taken when using the LHR device.
- (f) Each individual receiving the instructions must document that they have read and understand the instructions. The instructions and the documentation that each individual has read and understands the instructions must be maintained in accordance with §118.60.
- (g) A controlled area must be established within a room in which LHR devices are used and the LHR devices must be secure from unauthorized removal.
- (h) Each LHR device must incorporate a key-actuated or computer-actuated master control. The key must be removable and the LHR device must not be operable when the key is removed. When the LHR device is not being prepared for operation or is unattended, the controlled area must be secured to prevent unauthorized access.
(i) Protective eyewear must be worn by all individuals using an LHR device and all individuals present, including clients, in the room where an LHR device is being used. Protective eyewear devices must 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 12 months, to ensure the reliability of the protective filters and integrity of the protective filter frames. Unreliable eyewear must be discarded. Documentation of the examination must be made and maintained in accordance with §118.60.
- (j) Each client must 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.
- (k) Compliance with the written statement requirement specified in subsection (j), does not affect the liability of the LHR facility operator or a manufacturer of a LHR device.
- (l) Each LHR facility licensed by the department to offer LHR procedures using LHR devices in accordance with this chapter must confine use and possession of the LHR devices to the location and purpose authorized in the LHR facility application. If an LHR facility operator owns multiple LHR facilities, the operator may transfer an LHR device from facility to facility that the operator owns if each facility is licensed.
(m) An individual must not operate an LHR device with the intent to treat an illness, disease, injury, or physical defect or deformity unless the individual is:
- (1) a physician;
- (2) acting under a physician's order; or
- (3) authorized under other law to treat the illness, disease, injury, or physical defect or deformity in that manner.
- (n) A person who violates subsection (m), is practicing medicine in violation of Occupations Code, Title 3, Subtitle B, and is subject to the penalties under that subtitle and under Health and Safety Code §401.522.
- (o) An LHR facility must not be used for living or sleeping purposes, or any other purpose that would tend to make the premises unsanitary, unsafe, or endanger the health and safety of the public. A facility that is attached to a residence must have an entrance that is separate and distinct from the residential entrance. Any door between a residence and a licensed facility must be closed during business hours.
Source Note:The provisions of this §118.50 adopted to be effective October 1, 2025, 50 TexReg 6315.