Code of Federal Regulations Title 21. Food and Drugs § 21.878.4590 Focused ultrasound stimulator system for aesthetic use

(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.