FDA applicant
Beijing Winkonlaser Technology Limited
FDA records 2 decisions for Beijing Winkonlaser Technology Limited (Beijing, CN) from 2024 to 2026: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and NGX (Stimulator, Muscle, Powered, For Muscle…). Its devices cite 2 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 Beijing Winkonlaser Technology Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
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