FDA 510(k) K221623, FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm, by Gme German Medical Engineering GmbH
FDA 510(k) K221623, FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm, by Gme German Medical Engineering GmbH
| 510(k) Number | K221623 |
| Device Classification Name | Powered Laser Surgical Instrument |
| Device Name | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm |
| Applicant | Gme German Medical Engineering GmbH Dreikoenigstr. 6-8 Erlangen, DE 91054 |
| Regulation Number | 878.481 |
| Classification Product Code | GEX |
| Date Received | 06/06/2022 |
| Decision Date | 03/10/2023 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | General & Plastic Surgery |
| 510k Review Panel | General & Plastic Surgery |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 3330 |
| Redacted Pages | 2712 |
| Unredacted Pages | 618 |
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