Title 21: Food and Drugs
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/ PART 878 - GENERAL AND PLASTIC SURGERY DEVICES
/ Subpart F - Therapeutic Devices / § 878.5360 Tweezer-type epilator.
§ 878.5360 Tweezer-type epilator.
(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.