21 CFR 878.5400
§ 878.5400 Low level laser system for aesthetic use
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.5400, § 878.5400 Low level laser system for aesthetic use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90488
- Permanent ID
ys:prov:90488@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.