FDA applicant
Shenzhen Leaflife Technology Co., Ltd.
FDA records 7 decisions for Shenzhen Leaflife Technology Co., Ltd. (Shenzhen, CN) from 2020 to 2025: 7 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and 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 90 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 2 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 Leaflife 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 2020.
Planning a device like Shenzhen Leaflife Technology 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