K250189
- 510(k) number
- K250189
- Device name
- AdvaTx
- Applicant
- Advalight Aps DK
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-04-01
- Date received
- 2025-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K250189.pdf
Official FDA record: K250189
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.