---
kind: "section"
citation: "21 C.F.R. § 878.5400"
title: "21"
number: "878.5400"
heading: "Low level laser system for aesthetic use"
url: "https://uscodex.org/cfr/21/878.5400"
---

# §878.5400. Low level laser system for aesthetic use

- (a) **Identification.** A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.
- (b) **Classification.** Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser 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 20842, Apr. 14, 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 20842, Apr. 14, 2011]