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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 K201109
Device Name CO2 Laser Therapy System
Applicant
Shanghai Apolo Medical Technology Co., Ltd.
4F, Building A, No.388, Yindu Road, Xuhui District
Shanghai,  CN 200231
Applicant Contact Felix Li
Correspondent
Shanghai Landlink Medical Information Technology Co., Ltd.
Room 703, 705, Building 1,West Guangzhong Road 555
Jingan District
Shanghai,  CN 200071
Correspondent Contact Shelley Li
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/27/2020
Decision Date 07/15/2020
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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