21 CFR 878.4590
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.4590, § 878.4590 Focused ultrasound stimulator system for aesthetic use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90443
- Permanent ID
ys:prov:90443@1- SHA-256
a2ffa054aff2e319be7c3d35f93dd3565874a3e2deffffb54d65759298419ade
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.
(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator 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.