Code of Federal Regulations · Section
§ 878.5360 — Tweezer-type Epilator
21 C.F.R. § 878.5360
View:
(a) Identification. The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.
(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Authorizing Statute
-
Adulterated drugs and devices21 U.S.C. § 351