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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K260767
Device Name 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)
Applicant
Kam Yuen Plastic Products , Ltd.
# 2, Heng Feng Two Rd., Pu Jin Industrial, Konghou Town
Zhongshan,  CN 528447
Applicant Contact Shihe Wu
Correspondent
Guangdong Jianda Medical Technology Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Guangzhou,  CN 510663
Correspondent Contact Jett Lee
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
IRO   NFO   OLP  
Date Received03/09/2026
Decision Date 08/31/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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