21 CFR § 878.4340 - Contact cooling system for aesthetic use.

---
identifier: "/us/cfr/t21/s878.4340"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.4340 - Contact cooling system for aesthetic use."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.4340"
section_name: "Contact cooling system for aesthetic use."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---


# 878.4340 Contact cooling system for aesthetic use.

(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.

(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.

[76 FR 6553, Feb. 7, 2011]