Title 21: Food and Drugs
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/ PART 878 - GENERAL AND PLASTIC SURGERY DEVICES
/ Subpart F - Therapeutic Devices / § 878.5350 Needle-type epilator.
§ 878.5350 Needle-type epilator.
(a) Identification. A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.