21 CFR 878.5350 — Epilator, High Frequency, Needle-Type

General, Plastic Surgery (SU) · Part 878 Subpart F—Therapeutic Devices · § 878.5350

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.

Classification Rationale

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.

Product Codes