Marlborough, MA, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 4 | 2023-06-01 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 2 | 2024-07-01 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-07-01 | K240070 | Profound Matrix | GEI | Class II | General, Plastic Surgery |
| 2023-06-01 | K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | GEX | Class II | General, Plastic Surgery |
| 2022-10-13 | K220853 | PicoWay Laser System | GEX | Class II | General, Plastic Surgery |
| 2021-12-20 | K212492 | Frax 1940 for Nordlys and Frax Pro | GEX | Class II | General, Plastic Surgery |
| 2021-12-16 | K211217 | Profound Matrix | GEI | Class II | General, Plastic Surgery |
| 2020-05-26 | K201111 | GentleMax Pro Plus | GEX | Class II | General, Plastic Surgery |