FDA applicant
Hebei Keylaser Sci-Tech Co.,Ltd
FDA records 3 decisions for Hebei Keylaser Sci-Tech Co.,Ltd (Baoding, CN) from 2024 to 2025: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Hebei Keylaser Sci-Tech Co.,Ltd’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
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