LASEmaR 1500— 510(k) K260489
Substantially EquivalentEufoton S.R.L.
FDA 510(k) clearance K260489 for LASEmaR 1500, Substantially Equivalent on 2026-05-29. Applicant: Eufoton S.R.L.. Device class: 2.
Summary
Eufoton's LASEmaR 1500 is filed under GEX, powered laser surgical instruments.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Eufoton filed from Trieste, Italy. Review took 105 calendar days (February 13 to May 29, 2026).
Clearance details
- Applicant
- Eufoton S.R.L.
- 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
- Trieste, IT
Recent devices under product code GEX
view allMore clearances from Eufoton S.R.L.
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.