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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 K163655
Device Name Sparkling
Applicant
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
2f, Bldg. 3, Ln. 561, Nujiang Rd. (North),
Shanghai,  CN
Applicant Contact Amy Lee
Correspondent
Medwheat (Shanghai) Medical Technology Co. , Ltd.
Yangpu District Liaoyuan E. Rd. Shuangyang First Suite
# 33 Rm. 303
Shanghai,  CN 200093
Correspondent Contact Jonathan Hu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/23/2016
Decision Date 03/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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