21 CFR § 878.5400 - Low level laser system for aesthetic use

---
identifier: "/us/cfr/t21/s878.5400"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.5400 - Low level laser system for aesthetic use"
title_number: 21
title_name: "Food and Drugs"
section_number: "878.5400"
section_name: "Low level laser 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"
---


# 878.5400 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) for the availability of this guidance document.

[76 FR 20842, Apr. 14, 2011]