K260632
- 510(k) number
- K260632
- Device name
- LASER THERMAL THERAPY KIT
- Applicant
- Elesta S.P.A IT
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-03-17
- Date received
- 2026-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260632.pdf
Official FDA record: K260632
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.