---
kind: "section"
citation: "21 C.F.R. § 878.4790"
title: "21"
number: "878.4790"
heading: "Powered surgical instrument for improvement in the appearance of cellulite."
url: "https://uscodex.org/cfr/21/878.4790"
---

# §878.4790. Powered surgical instrument for improvement in the appearance of cellulite.

- (a) **Identification.** A powered surgical instrument for improvement in the appearance of cellulite is a prescription device that is used for the controlled release of subcutaneous tissue for improvement in the appearance of cellulite. The device consists of a cutting tool powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device.
  - (2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites.
  - (3) All elements of the device that may contact the patient must be demonstrated to be biocompatible.
  - (4) Electrical safety and electromagnetic compatibility of the device must be demonstrated.
  - (5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications.
  - (6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.

## Notes

### Amendments

[79 FR 31861, June 3, 2014]

### 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

[79 FR 31861, June 3, 2014]