510(k) Report

FDA applicant

Shandong Huamei Technology Co., Ltd.

Weifang, CN2 decisions2017–20240 recalls

FDA records 2 decisions for Shandong Huamei Technology Co., Ltd. (Weifang, CN) from 2017 to 2024: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and NGX (Stimulator, Muscle, Powered, For Muscle…). Its devices cite 3 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 Shandong Huamei Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12024: 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 — Shandong Huamei Technology Co., Ltd. by year, 2017–2026Sources: 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 Instrument1decision
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 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.

  • K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 20179cite it

What has FDA decided for it lately?

  • K232982EMS Sculpt MachineShandong Huamei Technology Co., Ltd. · 2024
  • K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017

All 2 as Shandong Huamei Technology Co., Ltd. →