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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 K250880
Device Name LED LIGHT MASK (A093)
Applicant
Foshan Guangyu Weilai Medical Equipment Co., Ltd.
201, Block A, Zhongfa Zhaochuang Science And Technology Park
River Village, Lishui Town, Nanhai District
Foshan,  CN 528226
Applicant Contact Guang Zhou
Correspondent
Wenzhou Thiwe Business Consulting Co., Ltd.
Rm. 1203, Bldg. C, Hua’Ou Jiayuan
#50 Tangjiaqiao S. Rd., Longwan District
Wenzhou,  CN 325000
Correspondent Contact Wendy Huang
Regulation Number878.4810
Classification Product Code
OHS  
Date Received03/24/2025
Decision Date 06/20/2025
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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