510(k) Report

FDA applicant

Shenzhen Ulike Smart Electronics Co., Ltd.

Shenzhen, CN23 decisions2022–20260 recalls

FDA records 23 decisions for Shenzhen Ulike Smart Electronics Co., Ltd. (Shenzhen, CN) from 2022 to 2026: 23 510(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 60 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 42 predicates, 16 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 Ulike Smart Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

9in 2025

2022: 12023: 22024: 82025: 92026 (partial year): 3
2022high 9 (2025) · low 1 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Shenzhen Ulike Smart Electronics Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Ulike Smart Electronics 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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