FDA applicant
Zhuozhou Summer Star Technologies Co., Ltd.
FDA records 1 decision for Zhuozhou Summer Star Technologies Co., Ltd. (Zhuozhou, CN) in 2025: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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 Zhuozhou Summer Star Technologies Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Zhuozhou Summer Star Technologies Co.…’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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