FDA applicant
Alovea Healthcare Co., Ltd.
FDA records 1 decision for Alovea Healthcare Co., Ltd. (Suzhou, CN) in 2025: 1 510(k) clearance. All are in product code OHT (Light Based Over-The-Counter Hair Removal). 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 Alovea Healthcare 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 Alovea Healthcare Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report