510(k) Report

FDA applicant

Shenzhen Nuon Medical Equipment Co., Ltd.

Shenzhen, CN6 decisions2024–20260 recalls

FDA records 6 decisions for Shenzhen Nuon Medical Equipment Co., Ltd. (Shenzhen, CN) from 2024 to 2026: 6 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and OAP (Laser, Comb, Hair). Since 2016 its 510(k)s took a median of 179 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 16 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 Shenzhen Nuon Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2024: 32025: 22026 (partial year): 1
2024high 3 (2024) · low 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Shenzhen Nuon Medical Equipment Co., Ltd. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Nuon Medical Equipment Co.…’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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