FDA applicant
Shenzhen Kaiyan Medical CO, Ltd.
FDA records 5 decisions for Shenzhen Kaiyan Medical CO, Ltd. (Shenzhen, CN) from 2021 to 2022: 5 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and OLP (Over-The-Counter Powered Light Based Laser For…). Since 2016 its 510(k)s took a median of 257 days from receipt to decision, against 162 for FDA’s reviews in the same codes and years. Its devices cite 9 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
How often FDA has decided Shenzhen Kaiyan Medical CO, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Shenzhen Kaiyan Medical CO, Ltd.’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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