FDA applicant
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
FDA records 6 decisions for Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd (Shanghai, CN) from 2016 to 2024: 6 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PKT (Laser For Disruption Of Adipocyte Cells For…). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 9 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 Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
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