510(k) Report

FDA applicant

Zhuzhou Goldenhot Medical Technology Co., Ltd.

Zhuzhou, CN3 decisions2023–20240 recalls

FDA records 3 decisions for Zhuzhou Goldenhot Medical Technology Co., Ltd. (Zhuzhou, CN) from 2023 to 2024: 3 510(k) clearances. Most are in product codes OHT (Light Based Over-The-Counter Hair Removal) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 82 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. 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 Zhuzhou Goldenhot Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2023: 12024: 2
2023high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Zhuzhou Goldenhot Medical Technology Co., Ltd. by year, 2023–2026Sources: 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 Removal2decisions
  • FLLContinuous Measurement Thermometer1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 82 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 2 of its 3 were faster than that.

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 2 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.

  • K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B…Zhuzhou Goldenhot Medical Technology Co., Ltd. · 20232cite it

What has FDA decided for it lately?

  • K243085IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2024
  • K240109Medical electronic thermometer (FC01, FC02)Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2024
  • K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B…Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2023

All 3 as Zhuzhou Goldenhot Medical Technology Co., Ltd. →