510(k) Report

FDA applicant

Zhongshan Bisen Plastic Electronic Products Co., Ltd.

Zhong Shan, CN2 decisions2017–20210 recalls

FDA records 2 decisions for Zhongshan Bisen Plastic Electronic Products Co., Ltd. (Zhong Shan, CN) from 2017 to 2021: 2 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and OHT (Light Based Over-The-Counter Hair Removal). 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 Zhongshan Bisen Plastic Electronic Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2017: 12021: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Zhongshan Bisen Plastic Electronic Products Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zhongshan Bisen Plastic Electronic…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

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

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 6 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.

  • K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 20175cite it
  • K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 20211cites it

What has FDA decided for it lately?

  • K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2021
  • K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2017

All 2 as Zhongshan Bisen Plastic Electronic Products Co., Ltd. →