{"data":{"id":"us/21-cfr-878.5350","jurisdiction":"us","citation":"21 CFR 878.5350","heading":"Needle-type epilator.","body":"(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.\n(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.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"48b2b1792d562b7502ba5d094713f53f5c52d8b03f4afb9482049379f5ae507b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.5080","next":"us/21-cfr-878.5360"},"notice":"GroundRules: Original legal text. Not legal advice."}