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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 With Microbeam\Fractional Output
510(k) Number K162398
Device Name CO2 Laser Therapy Systems
Applicant
Beijing Sincoheren Science and Technology Development Co.
Rm. 305, #43, Xizhimen N. St., Haidian District
Beijing,  CN 100044
Applicant Contact XIN WANG
Correspondent
Guangzhou Osmunda Medical Device Technology Service Co., Ltd.
7th Floor, Jingui Business Bldg.
#982 Congyun Rd., Baiyun District
Guangzhou,  CN 510420
Correspondent Contact MIKE GU
Regulation Number878.4810
Classification Product Code
ONG  
Subsequent Product Code
GEX  
Date Received08/26/2016
Decision Date 07/06/2017
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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