SofWave System
Device Facts
| Record ID | K231537 |
|---|---|
| Device Name | SofWave System |
| Applicant | Sofwave Medical, Ltd. |
| Product Code | OHV · General, Plastic Surgery |
| Decision Date | Aug 28, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4590 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
