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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 K191349
Device Name 980nm Diode Laser Therapy Device
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 claire zhang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/20/2019
Decision Date 08/16/2019
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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