Utah Admin. Code R156-11a-611 - Standards for Approval of Mechanical or Electrical Apparatus
Under Subsections 58-11a-102(45)(a)(i)(H)(II) and (I), the standards for approval of mechanical or electrical apparatus are:
(1) a
licensee may use a mechanical or electrical apparatus that is designated as a
prescription medical device by the FDA only 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(8)
by a master esthetician under general 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 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 shall:
(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 may not result in the removal of the epidermis beyond the
stratum corneum; and
(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.
Notes
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