64B8-56.002. Equipment and Devices; Protocols for Laser and Light-Based Devices

(1) The Board of Medicine approves the following equipment and devices for the permanent removal of hair by licensed electrologists if they are used pursuant to requirements established by the Board.

(a) Needle type epilators.

(b) Laser and light-based hair removal or reduction devices cleared by the United States Food and Drug Administration (FDA) for hair removal or reduction.

(2) An electrologist may use laser or light-based devices for hair removal or reduction only if they:

(a) Have completed training in:

1. Needle-type epilation and laser and light-based hair removal and reduction that meets the requirements set forth in subsections 64B8-52.004(2) and (3), F.A.C., and have passed the Society for Clinical and Medical Hair Removal test for certification as a Certified Medical Electrologist, or

2. Needle-type epilators combined with laser and light-based hair removal and reduction that meets the curriculum standards of Rule 64B8-53.002, F.A.C., and have passed a licensure examination approved by the Board in Rule 64B8-51.002, F.A.C., that tests both epilator and laser and light-based modalities;

(b) Are using only the laser and light-based hair removal or reduction devices upon which they have been trained; and,

(c) Are operating under the direct supervision and responsibility of a physician properly trained in hair removal and licensed pursuant to the provisions of Chapter 458 or 459, F.S.

1. For the purposes of this rule direct supervision and responsibility shall require the supervising physician be on the premises where laser hair removal is being performed or supervising the electrologist by means of telehealth as defined by section 456.47(1)(a), F.S., provided that:

a. The physician supervising by means of telehealth is located within 150 miles of the electrologist; and

b. The supervision is conducted in such a way as to allow continuous synchronous communication between the electrologist and the supervising physician.

2. Any electrologist who has been previously disciplined by the Board of Medicine shall not be eligible for supervision by means of telehealth until permitted to do so by Order of the Board of Medicine upon demonstration by the electrologist that they are able to practice safely with supervision by means of telehealth.

(3)(a) The supervising physician, initially upon assuming duties as the supervisor and semiannually thereafter, shall review and inspect the techniques, procedures, and equipment utilized by the electrologist in the performance of laser and light-based hair removal or reduction.

(b) The supervising physician shall ensure that the electrologist has received semi-annual training in the areas of infection control, sterilization, and emergency procedures.

(4)(a) The supervising physician and the electrologist shall develop jointly written protocols regarding;

1. The medical condition for individuals to receive laser and light-based hair removal or reduction treatment;

2. Specific conditions and the procedure for identifying conditions that require direct evaluation or specific consultation by the physician;

3. Treatment of routine minor problems resulting during or from laser and light-based hair removal or reduction;

4. Health issues or other conditions which would disqualify the use of supervision by means of telehealth for individual patients;

5. Safety limits and processes to ensure that direct supervision via telehealth is done in a safe manner; and

6. Detailed procedures to be followed in the event of emergency situations developing during the performance of or as a result of laser and light-based hair removal or reduction, including emergency procedures to use when supervision is conducted by means of telehealth.

(b) These written protocols must be signed, dated, and maintained in a readily available location on the premises where the electrologist practices. One copy shall be maintained by the supervising physician and one copy must be filed with the Department of Health. The written protocols which are kept on the premises of the electrologist will be readily available for inspection and review by agents of the Department of Health. The parties to a protocol must notify the Department within 30 days of the termination of their professional relationship.

(c) The written protocol shall include and require that the initial consultation with each patient must include an examination and assessment by a physician licensed pursuant to Chapter 458 or 459, F.S.

(5) Pursuant to Section 456.072(1)(i), F.S., any physician who knows that any electrologist is engaged in unsafe practice must report that electrologist to the Department of Health immediately.

(6) Any physician who provides supervision to an electrologist must keep the Board informed of the number of electrologists the physician is supervising. No physician is authorized to supervise more than four (4) electrologists at any one time whether in person or by means of telehealth.

Rulemaking Authority 458.331(1)(v), 478.43(1), (4) FS. Law Implemented 458.331(1)(v), 458.348(3), 478.42(5), 478.43(1), (3), (4) FS. History–New 9-12-01, Amended 2-28-02, 7-23-06, 3-12-08, 11-4-14, 2-15-17, 3-14-19, 11-10-19, 3-11-21.