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.
Clearance details
- Applicant
- Eufoton S.R.L.
- Product code
- 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
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- K262070 — Diode Laser Therapy Systems (DL612A)
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- K261221 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
More 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.