K250402
- 510(k) number
- K250402
- Device name
- AVAVA Skin Treatment System
- Applicant
- AVAVA, Inc. MA · US
- Product code
- ONG — Powered Laser Surgical Instrument With MicrobeamFrac
- Decision date
- 2025-04-14
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K250402.pdf
Official FDA record: K250402
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.