K261964
- 510(k) number
- K261964
- Device name
- ECHOLASER X4
- Applicant
- Elesta S.P.A IT
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-08-19
- Date received
- 2026-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K261964.pdf
Official FDA record: K261964
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.