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U.S. Department of Health and Human Services

Devices@FDA
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Help | Download Files | More about CDRH 510(K)

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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K162489
Device Name RED Light Device
Applicant
Zhongshan Bisen Plastic Electronic Products Co., Ltd.
F2,Bldg1,#8,Dongzhen N. Rd.,Zhangjiabian 1st Vil
Torch Development Zone
Zhong Shan,  CN 528437
Applicant Contact FengPing Li
Correspondent
Beijing Believe Technology Service Co., Ltd.
5-1206, Build 332, Dafangju, #25 Banbidian Rd.
Liyuan Town, Tongzhou District,  CN 101121
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
OHS  
Date Received09/07/2016
Decision Date 01/13/2017
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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