Panels › General, Plastic Surgery › Product code OHV · Class 2
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Regulation 878.4590
1510(k)s in 12 months (30 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in OHV
| Company | 510(k)s | Recalls |
|---|---|---|
| Ulthera, Inc. | 10 | 0 |
| Sofwave Medical, Ltd. | 9 | 0 |
| Syneron Medical, Ltd. | 6 | 0 |
| Medicis Technologies Corporation | 2 | 0 |
| Beshape Technologies , Ltd. | 1 | 0 |
| Classys, Inc. | 1 | 0 |
| Jeisys Medical, Inc. | 1 | 0 |
| RoyalVibe Health Ltd. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2023 | RoyalVibe Health Ltd. CellQuicken Analyzer (Smart-Watch and Software),
RoyalVibe Ultrasound Generator,
Brainvibe,
Envirovibe Water Restructuring Pad,
RoyalVibe Therapy Balls Open, Classified |
OHV | None listed |
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