FDA applicant
Shenzhen Siken 3D Technology Development Co., Ltd.
FDA records 6 decisions for Shenzhen Siken 3D Technology Development Co., Ltd. (Shenzhen, CN) from 2017 to 2025: 6 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and OHT (Light Based Over-The-Counter Hair Removal). Since 2016 its 510(k)s took a median of 117 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 10 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
How often FDA has decided Shenzhen Siken 3D Technology Development Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
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