FDA applicant
Shenzhen Fansizhe Science and Technology Co., Ltd.
FDA records 5 decisions for Shenzhen Fansizhe Science and Technology Co., Ltd. (Shenzhen, CN) from 2022 to 2025: 5 510(k) clearances. All are in product code OHT (Light Based Over-The-Counter Hair Removal). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 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 Fansizhe Science and Technology 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 2022.
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