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Sofwave Applicator
SOFWAVE MEDICAL LTD · Model FG00002 · UDI-DI 07290018152010
OHV
Prescription
5
510(k) clearances
216
Adverse events
1
Recalls
17
Facilities
Description
The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System consists of two main functional components: 1) the console and 2) the applicator. The applicator component of SofWave System exists in three forms to allow the user treatment flexibility, This applicator is the regular size (lift) applicator, designed with flat tip to allow the user treatment flexibility and easier access to all treatment areas.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-30 | RoyalVibe Health Ltd. | Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of cust |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.