Nd: YAG Laser Therapy Systems

Powered Laser Surgical Instrument

Beijing Kes Biology Technology Co., Ltd.

The following data is part of a premarket notification filed by Beijing Kes Biology Technology Co., Ltd. with the FDA for Nd: Yag Laser Therapy Systems.

Pre-market Notification Details

Device IDK193477
510k NumberK193477
Device Name:Nd: YAG Laser Therapy Systems
ClassificationPowered Laser Surgical Instrument
Applicant Beijing Kes Biology Technology Co., Ltd. No. 15, Zone 2,Mafang Industrial Park, PingguyuanZhongguancun Science And Te Beijing,  CN 101204
ContactWei Meng Meng
CorrespondentDaina Hong
Mid-Link Consulting Co., Ltd. P.O. Box. 120-119 Shanghai,  CN 200120
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-16
Decision Date2020-06-24

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