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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 K254007
Device Name LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)
Applicant
SZ KKS Silicone&Electronic Co., Ltd.
#9,6 Rd.,Tai Wai, Xinqiao Community
Xingiao Strcet, Bao'An District
Shenzhen,  CN
Applicant Contact Yongquan Luo
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Rm. 2231, Bldg. 1, Ruifeng Center
Kaichuang Rd., Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received12/15/2025
Decision Date 02/12/2026
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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