Wesford, MA, US · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 4 | 2026-06-17 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 2 | 2022-11-23 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General, Plastic Surgery | 1 | 2023-07-06 |
| PBX | — | — | — | 1 | 2020-03-25 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-17 | K261570 | PICOSURE WORKSTATION | GEX | Class II | General, Plastic Surgery |
| 2024-03-08 | K240396 | Elite iQ PRO (M122K1) | GEX | Class II | General, Plastic Surgery |
| 2023-07-06 | K230510 | MyEllevate | GAT | Class II | General, Plastic Surgery |
| 2022-11-23 | K223292 | TempSure System | GEI | Class II | General, Plastic Surgery |
| 2022-03-18 | K212891 | TempSure System | GEI | Class II | General, Plastic Surgery |
| 2021-03-30 | K210226 | PicoSure Workstation | GEX | Class II | General, Plastic Surgery |
| 2020-03-25 | K200241 | TempSure System | PBX | — | — |
| 2020-03-09 | K193426 | Elite iQ | GEX | Class II | General, Plastic Surgery |