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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 K152898
Device Name DIODE LASER THERAPY SYSTEMS
Applicant
BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD
ROOM 305, NO.43, XIZHIMEN NORTH STREET
HAIDIAN DISTRICT
BEIJING,  CN 100044
Applicant Contact XIN WANG
Correspondent
GUANGZHOU OSMUNDA MEDICAL DEVICE TECHNOLOGY SERVICE CO., LTD
7TH FLOOR, JINGUI BUSINESS BUILDING, NO.982 CONGYUN RD
BAIYUN DISTRICT
GUANGZHOU,  CN 510420
Correspondent Contact MIKE GU
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/01/2015
Decision Date 02/09/2016
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
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