510(k) Report

FDA applicant

Wuhan Gigaa Optronics Technology Co., Ltd.

#818 Gaoxin Avenue, East Lake Developmen, CN2 decisions2015–20170 recalls

FDA records 2 decisions for Wuhan Gigaa Optronics Technology Co., Ltd. (#818 Gaoxin Avenue, East Lake Developmen, CN) from 2015 to 2017: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 4 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 Wuhan Gigaa Optronics Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2015: 12017: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Wuhan Gigaa Optronics Technology Co., Ltd. by year, 2015–2026Sources: 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 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 20153cite it
  • K160549Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 20172cite it

What has FDA decided for it lately?

  • K160549Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2017
  • K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015

All 2 as Wuhan Gigaa Optronics Technology Co., Ltd. →