LASER THERMAL THERAPY KIT— 510(k) K260632
Substantially EquivalentElesta S.P.A
FDA 510(k) clearance K260632 for LASER THERMAL THERAPY KIT, Substantially Equivalent on 2026-03-17. Applicant: Elesta S.P.A. Device class: 2.
Summary
Elesta's LASER THERMAL THERAPY KIT is filed under GEX, powered laser surgical instruments. The name is generic, and the record doesn't list what the kit contains.
Class II, 21 CFR 878.4810. It was a Special 510(k), and General and Plastic Surgery is both the classification panel and the review panel.
Elesta filed from Calenzano, Italy. The decision came 19 calendar days after FDA received it (February 26 to March 17, 2026).
Clearance details
- Applicant
- Elesta S.P.A
- Product code
- Product code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Calenzano, IT
Recent devices under product code GEX
view allMore clearances from Elesta S.P.A
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.