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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 K251588
Device Name LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
Applicant
Shenzhen Fittop Health Technology Co., Ltd.
3, 6, 8/F, Bldg. 3, #7, Langfeng Rd., Xinshi, Community
Dalang, Longhua District
Shenzhen,  CN 518000
Applicant Contact Sandy Lee
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90
Qianhai Rd., Nanshan District
Shenzhen,  CN 518052
Correspondent Contact Youshan Gong
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
ILY   OLP  
Date Received05/23/2025
Decision Date 08/21/2025
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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