FDA applicant
Shenzhen Ionka Medical Technology Co., Ltd.
FDA records 2 decisions for Shenzhen Ionka Medical Technology Co., Ltd. (Shenzhen, CN) from 2022 to 2023: 2 510(k) clearances. Most are in product codes OHT (Light Based Over-The-Counter Hair Removal) and ONF (Powered Light Based Non-Laser Surgical…). 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
How often FDA has decided Shenzhen Ionka Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
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