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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, Bldg. A, #388, Yindu Rd., Xuhui District
Shanghai,  CN 200231
Applicant Contact Felix Li
Correspondent
Shanghai Landlink Medical Information Technology Co., Ltd.
Rm. 703, 705 , Bldg. 1, W. Guangzhong Rd. 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
Predetermined Change
Control Plan Authorized		 No
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