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Ulthera System Control Unit PRIME

Ulthera, Inc. · Model UC-1 Control Unit (PRIME) Rev. A · UDI-DI 00840763101145

OHVIYO Prescription
10
510(k) clearances
216
Adverse events
1
Recalls
17
Facilities

Recalls

DateFirmReason
2023-08-30RoyalVibe 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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Data 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.