ECHOLASER X4— 510(k) K261964
Substantially EquivalentElesta S.P.A
FDA 510(k) clearance K261964 for ECHOLASER X4, Substantially Equivalent on 2026-08-19. Applicant: Elesta S.P.A. Device class: 2.
Summary
Elesta's ECHOLASER X4 is filed under product code GEX, powered laser surgical instruments. The record has no description beyond the name and that code.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. The submission was a Traditional 510(k).
Elesta filed from Calenzano, Italy. The decision came 69 calendar days after FDA received it (June 11 to August 19, 2026), and it was substantially equivalent.
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
- Traditional
- 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.