FDA applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd.
FDA records 24 decisions for Shenzhen Kaiyan Medical Equipment Co., Ltd. (Shenzhen, CN) from 2023 to 2026: 24 510(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 89 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 63 predicates, 6 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 Kaiyan Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
11in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
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