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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 K252264
Device Name MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)
Applicant
Shenzhen Zhenxing Ruitong Technology Co., Ltd.
Rm. 25c, Microsoft Science And Technology Bldg.
Nanshan District
Shenzhen,  CN 518000
Applicant Contact Li Guoyang
Correspondent
Shenzhen Zhenxing Ruitong Technology Co., Ltd.
Rm. 25c, Microsoft Science And Technology Bldg.
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Li Guoyang
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received07/21/2025
Decision Date 10/17/2025
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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