Home › Device types › OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
FDA product code OHV · Class 2 · General, Plastic Surgery
71
Registered devices
216
Adverse events
1
Recalls
30
510(k) clearances
Devices with this code
Ulthera System Handpiece — Ulthera, Inc.Sofwave Applicator — SOFWAVE MEDICAL LTDUlthera System Handpiece — Ulthera, Inc.Liposonix — SOLTA MEDICALUlthera System Control Unit — Ulthera, Inc.Ulthera System Transducer — Ulthera, Inc.Liposonix — SOLTA MEDICALUlthera System Transducer — Ulthera, Inc.Liposonix — SOLTA MEDICALUlthera System Transducer — Ulthera, Inc.Ulthera System Transducer — Ulthera, Inc.Ulthera System Transducer — Ulthera, Inc.Ulthera System — Ulthera, Inc.Sofwave Applicator — SOFWAVE MEDICAL LTDUlthera System Handpiece — Ulthera, Inc.Sofwave Applicator — SOFWAVE MEDICAL LTDUlthera System Handpiece — Ulthera, Inc.VDF Transducer, Ultrashape — SYNERON MEDICAL LTDUlthera System Transducer — Ulthera, Inc.UltraShape Power System, Packaged — SYNERON MEDICAL LTDUlthera System Handpiece — Ulthera, Inc.Sofwave Applicator — SOFWAVE MEDICAL LTDUlthera System Control Unit — Ulthera, Inc.UltraShape system — SYNERON MEDICAL LTD
Recent 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 |
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