510(k) Report

FDA applicant

Eufoton S.R.L.

Trieste, IT2 decisions2010–20260 recalls

FDA records 2 decisions for Eufoton S.R.L. (Trieste, IT) from 2010 to 2026: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Eufoton S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 12026 (partial year): 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Eufoton S.R.L. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092860Lasemar 800, 1000, 1500Eufoton S.R.L. · 20101cites it

What has FDA decided for it lately?

  • K260489LASEmaR 1500Eufoton S.R.L. · 2026
  • K092860Lasemar 800, 1000, 1500Eufoton S.R.L. · 2010

All 2 as Eufoton S.R.L. →