K233550
- 510(k) number
- K233550
- Device name
- MOSAIC 3D (Surgical Laser)
- Applicant
- Lutronic Aesthetic MA · US
- Product code
- ONG — Powered Laser Surgical Instrument With MicrobeamFrac
- Decision date
- 2024-01-02
- Date received
- 2023-11-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233550.pdf
Official FDA record: K233550
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.