K240497
- 510(k) number
- K240497
- Device name
- Smartxide Tetra Pro
- Applicant
- El.En S.P.A. IT
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-03-12
- Date received
- 2024-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240497.pdf
Official FDA record: K240497
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.