21 CFR 878.5360 — Epilator, High Frequency, Tweezer-Type

General, Plastic Surgery (SU) · Part 878 Subpart F—Therapeutic Devices · § 878.5360

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KCXEpilator, High Frequency, Tweezer-Type125
Innolitics

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