GroundRules
21 CFR 878.5360: Tweezer-type epilator.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 878—GENERAL AND PLASTIC SURGERY DEVICES
- Subpart F—Therapeutic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON