FDA cleared the Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) from Kam Yuen Plastic Products , Ltd. on Aug 31, 2026 under K260767, a traditional 510(k). The device falls under product code OHS, Light Based Over The Counter Wrinkle Reduction, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Mar 9, 2026. The decision came 175 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Kam Yuen Plastic Products , Ltd. in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K260767?
K260767 is the FDA 510(k) for Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907), submitted by Kam Yuen Plastic Products , Ltd.. FDA's decision date was Aug 31, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).
Who makes the Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)?
Kam Yuen Plastic Products , Ltd., based in Zhongshan, is the applicant of record for K260767.
How long did the K260767 review take?
FDA received the submission on Mar 9, 2026 and issued its decision on Aug 31, 2026, 175 days later.