R156-11a-611. Standards for Approval of Mechanical or Electrical Apparatus  


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  •   In accordance with Subsections 58-11a-102(39)(a)(i)(G)(II) and (H), the standards for approval of mechanical or electrical apparatus are:

      (1) No mechanical or electrical apparatus that is considered a prescription medical device by the FDA may be used by a licensee, unless such use is completed under the appropriate level of supervision by a licensed health care practitioner acting within the licensed health care practitioner's scope of practice.

      (2) Dermaplane procedures, dermabrasion procedures, blades, knives, and lancets are prohibited except for:

      (a) advanced pedicures;

      (b) advanced extraction of impurities from the skin; and

      (c) dermaplane procedures for advanced exfoliation as defined in Subsection R156-11a-102(7) by a master esthetician under direct supervision of a health care practitioner.

      (3) The use of any procedure in which human tissue is cut or altered by laser energy or ionizing radiation is prohibited for all individuals licensed under this chapter unless it is within the scope of practice for the licensee and under the appropriate level of supervision by a licensed health care practitioner acting within the licensed health care practitioner's scope of practice.

      (4) To be approved, a microdermabrasion machine must:

      (a) be specifically labeled for cosmetic or esthetic purposes;

      (b) be a closed-loop vacuum system that uses a tissue retention device; and

      (c) the normal and customary use of the machine does not result in the removal of the epidermis beyond the stratum corneum.

      (5) To be approved, a microneedling device shall:

      (a) be used only by a master esthetician:

      (i) without supervision if needle penetration does not exceed 1.5 mm; or

      (ii) with general supervision by a licensed health care practitioner if needle penetration exceeds 1.5 mm; and

      (b) be used specifically for cosmetic or esthetic purposes.