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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Light Induced Heating
510(k) Number K161892
Device Name Slimming Treatment Device
Applicant
Beijing Honkon Technologies Co., Ltd.
72 Bldg., Golden Bridge S&T Indus. Base, 16# Huanke Mid Rd.
Tongzhou Dist.
Beijing,  CN 101102
Applicant Contact Li Yanzhe
Correspondent
Beijing Believe Technology Service Co., Ltd.
5-1206, Build 332, Dafangju, #25 Banbidian Rd.
Liyuan Town, Tongzhou
Beijing,  CN 101121
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
NUV  
Subsequent Product Code
ISA  
Date Received07/11/2016
Decision Date 03/02/2017
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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