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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K161565
Device Name DUO
Applicant
STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD
10-11th Floor, Bensi Building, New High-Tech-Park,
Ganli Village, Buji District
Shenzhen,  CN
Applicant Contact Juan Ye
Correspondent
SGS-CSTC Standards Technical Services Co., Ltd.
198 KEZHU Road, SCIENTECH Park Guangzhou
Guangzhou,  CN
Correspondent Contact Iris Fung
Regulation Number878.4810
Classification Product Code
ONF  
Subsequent Product Code
OHT  
Date Received06/06/2016
Decision Date 09/01/2016
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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