K240816
- 510(k) number
- K240816
- Device name
- MeDioStar
- Applicant
- Asclepion Laser Technologies GmbH DE
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-04-23
- Date received
- 2024-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K240816.pdf
Official FDA record: K240816
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.