1. (a) An LHR device used for laser hair removal in a LHR facility must follow all applicable federal and state laws and regulations.

2. (b) An LHR facility must notify the department within 30 days after any change to the following:

   1. (1) business name of the LHR facility;
   2. (2) physical location of the LHR facility;
   3. (3) street address where LHR devices will be used;
   4. (4) LHR professional designated for the facility; or
   5. (5) consulting physician or alternate consulting physician for the facility.
3. (c) The LHR facility must follow the adverse reporting requirements for device user facilities in Title 21, CFR, Part 803 - Medical Device Reporting. Copies of all reports of adverse events submitted in accordance with Title 21, CFR, Part 803 must be submitted to the department within 24 hours of their initial submission to the manufacturer, FDA or both as determined by the consulting physician in accordance with §118.13.
4. (d) If an LHR facility loses the services of the consulting physician, the facility may use the alternate consulting physician designated in the contract in accordance with §118.10, and the LHR facility must contract with a new consulting physician within 30 calendar days. If an LHR facility loses the services of both consulting physicians, the LHR facility must immediately cease LHR procedures until the LHR facility establishes a new contractual relationship with a consulting physician and alternate consulting physician. All new contracts must be sent to the department within 30 days.

5. (e) Each LHR facility must conduct and maintain a physical inventory of all LHR devices in its possession at an interval not to exceed one year. Records of the inventories must be made and maintained in accordance with §118.60, and must include:

   1. (1) LHR device manufacturer's name;
   2. (2) model and serial number of the LHR device;
   3. (3) specific location of the LHR device (for example, room number);
   4. (4) name, title, and signature of the person performing the inventory; and
   5. (5) date the inventory was performed.

6. (f) Each LHR facility must maintain records of receipt, transfer, and disposal for each LHR device in accordance with §118.60. The records must include the following information:

   1. (1) LHR manufacturer's name;
   2. (2) model and serial number of the LHR device;
   3. (3) date of the receipt, transfer, or disposal;
   4. (4) name and address of person LHR devices were received from, transferred to, or disposed of with; and
   5. (5) name of the individual recording the information.
7. (g) An operator is responsible for maintaining the LHR facility's compliance with the requirements of the Act and this chapter.
8. (h) An operator must not claim, advertise, or distribute promotional materials claiming that laser hair removal is free from risk or provides any medical benefit.
9. (i) An operator must not produce false or misleading advertising regarding the services offered at the facility.

10. (j) When an LHR facility ends all activities requiring an LHR facility license, the LHR facility must immediately submit to the department:

    1. (1) a written request for termination of the LHR facility license; and
    2. (2) a record of the disposition of the LHR devices, and if transferred, to whom the devices were transferred, as specified in §118.12(f).

11. (k) A warning sign must be posted in a conspicuous location that is readily visible to a person entering the LHR facility. The warning sign must meet the following requirements:

    1. (1) be of a size with dimensions at least 8 and 1/2 inches by 11 inches;
    2. (2) contain wording with a font size no smaller than size 26;

    3. (3) contain at least the following wording:

       1. (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.
       2. (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.
12. (l) The LHR controlled area must be conspicuously posted with signs or labels as prescribed by applicable federal and state laws and regulations.
13. (m) An LHR facility license is not transferrable.
14. (n) Except as provided by subsection (o), an LHR facility must have an LHR professional present to provide supervision of the LHR procedures performed at the facility during the facility's operating hours.

15. (o) If an LHR facility loses the services of the LHR professional, or the LHR professional is continuously absent for up to 44 calendar days, the LHR facility must not continue to offer LHR services unless the LHR facility has a senior LHR technician present to perform or directly supervise each procedure. By the 45th day after the date the LHR professional leaves or is continuously absent from the facility:

    1. (1) the facility's senior LHR technician must become certified as an LHR professional in accordance with this chapter; or
    2. (2) the facility must hire a new LHR professional.

Source Note:The provisions of this §118.12 adopted to be effective October 1, 2025, 50 TexReg 6315.