(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.