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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K161692
Device Name Diode Laser Therapy Machine
Applicant
Beijing Adss Development Co., Ltd.
F6, Xiando Bldg., Jinyuan Rd. 36,
Daxing Economic Development Zone
Beijing,  CN 102628
Applicant Contact GAO YURONG
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
GEX  
Date Received06/20/2016
Decision Date 11/16/2016
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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