510(k) Report

FDA applicant

Hunan Guangye Biotechnology Co., Ltd.

Changsha City, CN2 decisions2022–20220 recalls

FDA records 2 decisions for Hunan Guangye Biotechnology Co., Ltd. (Changsha City, CN) in 2022: 2 510(k) clearances. Most are in product codes OHT (Light Based Over-The-Counter Hair Removal) and OHS (Light Based Over The Counter Wrinkle Reduction). Its devices cite 2 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 Hunan Guangye Biotechnology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2022: 2
2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Hunan Guangye Biotechnology Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OHTLight Based Over-The-Counter Hair Removal1decision
  • OHSLight Based Over The Counter Wrinkle Reduction1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd. · 20224cite it

What has FDA decided for it lately?

  • K222432IPL Hair Removal Device, Model (s): KCA423, KCA437, KCA439Hunan Guangye Biotechnology Co., Ltd. · 2022
  • K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd. · 2022

All 2 as Hunan Guangye Biotechnology Co., Ltd. →