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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 K243423
Device Name LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)
Applicant
Shenzhen Rainbow Technology Co., Ltd.
5th Floor, Bldg. C, Fenda Technology Innovation Park,
Xixiang, Baoan District
Shenzhen,  CN 518000
Applicant Contact Layla Li
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Jilan Luo
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
ILY   OLP  
Date Received11/04/2024
Decision Date 01/28/2025
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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