K250504
- 510(k) number
- K250504
- Device name
- Leonardo Duster
- Applicant
- Ceramoptec GmbH DE
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-07-14
- Date received
- 2025-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250504.pdf
Official FDA record: K250504
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.