510(k) Report

FDA applicant

Wuhan Dimed Laser Technology Co., Ltd.

Wuhan, CN2 decisions2021–20250 recalls

FDA records 2 decisions for Wuhan Dimed Laser Technology Co., Ltd. (Wuhan, CN) from 2021 to 2025: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 3 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 Wuhan Dimed Laser Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12025: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Wuhan Dimed Laser Technology Co., Ltd. by year, 2021–2026Sources: 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 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K211977Medical Diode Laser SystemsWuhan Dimed Laser Technology Co., Ltd. · 20213cite it

What has FDA decided for it lately?

  • K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
  • K211977Medical Diode Laser SystemsWuhan Dimed Laser Technology Co., Ltd. · 2021

All 2 as Wuhan Dimed Laser Technology Co., Ltd. →