Panels › General, Plastic Surgery › Product code PBX · Class 2
Massager, Vacuum, Radio Frequency Induced Heat
Regulation 878.4400
6510(k)s in 12 months (81 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PBX
| Company | 510(k)s | Recalls |
|---|---|---|
| Bios S.R.L. | 5 | 1 |
| Venus Concept , Ltd. | 6 | 0 |
| BTL Industries, Inc. | 5 | 0 |
| Cutera, Inc. | 5 | 0 |
| Inmode MD , Ltd. | 5 | 0 |
| Viora , Ltd. | 4 | 0 |
| Capenergy Medical S.L. | 3 | 0 |
| Swims America Corp | 3 | 0 |
| Weero Co. | 3 | 0 |
| CAO Group, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2017 | Bios S.r.l. THERMI250 Radiofrequency System.
Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions. Terminated |
PBX | K151296 |
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