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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 K242638
Device Name LED Light Therapy Machine (G1, G3, G4, G6)
Applicant
Shenzhen Walton Technology Co., Ltd.
Rm. 801, Jiaxiye Plz., # 318 Minzhi Ave.,
Minzhi Community, Minzhi St., Longhua District
Shenzhen City,  CN 518131
Applicant Contact Zhou Ling
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu Distr
Guangzhou,  CN 510530
Correspondent Contact Cassie Lee
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
ILY   OLP  
Date Received09/03/2024
Decision Date 11/27/2024
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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