K243683
- 510(k) number
- K243683
- Device name
- Deka Bluebeam
- Applicant
- El.En S.P.A. IT
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-06-12
- Date received
- 2024-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243683.pdf
Official FDA record: K243683
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.