K250281
- 510(k) number
- K250281
- Device name
- DEKA LOTUS
- Applicant
- El.En S.P.A. IT
- Product code
- ONF — Powered Light Based Non-Laser Surgical Instrument Wi
- Decision date
- 2025-02-26
- Date received
- 2025-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250281.pdf
Official FDA record: K250281
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.