510(k) Report

FDA applicant

Zolar Technology & Mfg Co., Inc.

Great Neck, NY2 decisions2013–20160 recalls

FDA records 2 decisions for Zolar Technology & Mfg Co., Inc. (Great Neck, NY) from 2013 to 2016: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 5 predicates, 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 Zolar Technology & Mfg Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2013: 12016: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Zolar Technology & Mfg Co., Inc. by year, 2013–2026Sources: 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

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K122020Photon Photon PlusZolar Technology & Mfg Co., Inc. · 20131cites it
  • K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 20161cites it

What has FDA decided for it lately?

  • K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016
  • K122020Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013

All 2 as Zolar Technology & Mfg Co., Inc. →