Panels › General, Plastic Surgery › Product code GEX · Class 2
Powered Laser Surgical Instrument
Regulation 878.4810
71510(k)s in 12 months (2,892 all time)
6recalls in 12 months (201 all time)
150recalls that name a 510(k)
Top companies in GEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cynosure, Inc. | 84 | 1 |
| Lumenis | 60 | 11 |
| Sharplan Lasers, Inc. | 66 | 0 |
| Quanta System Spa | 57 | 6 |
| Candela Corp. | 53 | 5 |
| Laserscope | 49 | 0 |
| Trimedyne, Inc. | 48 | 0 |
| Heraeus Lasersonics, Inc. | 37 | 0 |
| Surgical Laser Technologies, Inc. | 35 | 0 |
| Boston Scientific | 11 | 23 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2003 | A.R.C. Laser Corp A.R.C. Laser Photolysis Probe/Handpiece Terminated |
GEX | K993154 |
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