K232858
- 510(k) number
- K232858
- Device name
- ORskin Blue
- Applicant
- Megabay S.A. AR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-05-01
- Date received
- 2023-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K232858
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.