{"data":{"id":"us/21-cfr-878.4340","jurisdiction":"us","citation":"21 CFR 878.4340","heading":"Contact cooling system for aesthetic use.","body":"(a) Identification. A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.\n(b) Classification. Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.","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 E—Surgical 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":"76ba5154938b6e0db1d74ed48faeecf6e5425789c1d7e9c0152ecbc0d25221e7","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4320","next":"us/21-cfr-878.4350"},"notice":"GroundRules: Original legal text. Not legal advice."}