K250809
- 510(k) number
- K250809
- Device name
- Stellar M22
- Applicant
- Lumenis Be, Ltd. IL
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-04-16
- Date received
- 2025-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K250809.pdf
Official FDA record: K250809
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.