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Ulthera System Handpiece
Ulthera, Inc. · Model UH-2 Rev. G · UDI-DI 00840763100421
1
510(k) clearances
216
Adverse events
1
Recalls
17
Facilities
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.