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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 K193477
Device Name Nd: YAG Laser Therapy Systems
Applicant
Beijing Kes Biology Technology Co., Ltd.
# 15, Zone 2,Mafang Industrial Park,
Pingguyuanzhongguancun Science And Te
Beijing,  CN 101204
Applicant Contact Wei Meng Meng
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Daina Hong
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/16/2019
Decision Date 06/24/2020
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
Predetermined Change
Control Plan Authorized		 No
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