---
kind: "section"
citation: "21 C.F.R. § 878.4340"
title: "21"
number: "878.4340"
heading: "Contact cooling system for aesthetic use."
url: "https://uscodex.org/cfr/21/878.4340"
---

# §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)](/cfr/21/878.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[76 FR 6553, Feb. 7, 2011]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[76 FR 6553, Feb. 7, 2011]