The Council proposes the development of a rule amendment to address equipment and devices; protocols for laser and light-based devices.

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

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

PURPOSE AND EFFECT: The Council proposes the development of a rule amendment to address equipment and devices; protocols for laser and light-based devices.

SUMMARY: Update rule language regarding equipment and devices; protocols for laser and light-based devices.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has been prepared by the Agency.

The following is a summary of the SERC: Licensed Electrologists desiring to offer laser and light-based hair removal services will be impacted by the proposed rule amendments. The Division of Medical Quality Assurance’s Annual Report indicates there were over 1,600 licensed Electrologists in fiscal year 2016-2017. Of that number, approximately 168 licensed Electrologists had the required protocols on file indicating practice in laser hair removal. With the more efficient pathway to offering laser and light-based hair removal services as an Electrologist, the number of practitioners providing the service is expected to increase. The proposed changes, however, will not require ratification of the legislature.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

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.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Allen Hall, Executive Director, Board of Medicine; Electrolysis Council, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253, [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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

(1) No change.

(2) An electrologist may not use laser or light-based devices for hair removal or reduction only if unless 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 (b) hHave 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 of 64B8-53.002, F.A.C., and have passed a licensure examination approved by the Board in 64B8-51.002, F.A.C., that tests both epilator and laser and light-based modalities;

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

(c)(d) 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.

(3) through (6) No change.

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,               .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Electrolysis Council

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 8, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 18, 2017