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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 K180967
Device Name Dental Diode Laser System
Applicant
Lazon Medical Laser Co., Ltd.
#123, Hezuo St., Dadong District
Shenyang,  CN 110179
Applicant Contact Gen Cheng
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/13/2018
Decision Date 07/11/2018
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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