510(k) Report

FDA applicant

Shenzhen Chuangtong Yigou Technology Co., Ltd.

Shenzhen, CN3 decisions2025–20260 recalls

FDA records 3 decisions for Shenzhen Chuangtong Yigou Technology Co., Ltd. (Shenzhen, CN) from 2025 to 2026: 3 510(k) clearances. Most are in product codes OHT (Light Based Over-The-Counter Hair Removal) and OHS (Light Based Over The Counter Wrinkle Reduction). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Chuangtong Yigou Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 12026 (partial year): 2
2025high 2 (2026) · low 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Shenzhen Chuangtong Yigou Technology Co., Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Chuangtong Yigou Technology…’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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