FDA applicant
Kam Yuen Plastic Products, Ltd.
FDA records 6 decisions for Kam Yuen Plastic Products, Ltd. (Zhongshan, CN) from 2019 to 2026: 6 510(k) clearances. Most are in product codes OHT (Light Based Over-The-Counter Hair Removal) and OAP (Laser, Comb, Hair). Since 2016 its 510(k)s took a median of 180 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 13 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 Kam Yuen Plastic Products, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Kam Yuen Plastic Products, 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