510(k) Report

FDA applicant

G.N.S Neolaser, Ltd.

Caesarea, IL3 decisions2014–20250 recalls

FDA records 3 decisions for G.N.S Neolaser, Ltd. (Caesarea, IL) from 2014 to 2025: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 6 predicates, 0 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 G.N.S Neolaser, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 12015: 12025: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — G.N.S Neolaser, Ltd. by year, 2014–2026Sources: 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 Instrument3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd. · 20155cite it
  • K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd. · 20142cite it

What has FDA decided for it lately?

  • K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd. · 2025
  • K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd. · 2015
  • K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd. · 2014

All 3 as G.N.S Neolaser, Ltd. →