FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
FDA 510(k) clearance K221623 · decided 2023-03-10
Clearance details
- K-number
- K221623
- Device name
- FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
- Applicant
- Gme German Medical Engineering GmbH
- Decision
- Substantially Equivalent
- Date received
- 2022-06-06
- Decision date
- 2023-03-10
- Days to decision
- 277 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Erlangen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.