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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 K243141
Device Name Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)
Applicant
Jiangxi Medex Technology Co., Ltd.
Chengxin Ave., Xinfeng Industrial Area Xinfeng
Jiangxi,  CN 341601
Applicant Contact Zhang Kaixia
Correspondent
Microkn Medical Technology Service (Shanghai) Co., Ltd.
Rm. 901, #889, Pinglu Rd., Jing'An District
Shanghai,  CN
Correspondent Contact Owen He
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/30/2024
Decision Date 12/26/2024
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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