FDA applicant
Shenzhen Mlay Intelligent Technology Co.,, Ltd.
FDA records 4 decisions for Shenzhen Mlay Intelligent Technology Co.,, Ltd. (Shenzhen, CN) from 2024 to 2026: 4 510(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 66 days from receipt to decision, against 73 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Shenzhen Mlay Intelligent Technology Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen Mlay Intelligent Technology 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 2024.
Planning a device like Shenzhen Mlay Intelligent Technology…’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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