Q Switched Nd: YAG Laser Machine

Powered Laser Surgical Instrument

Beijing Lead Beauty S & T Co., Ltd

The following data is part of a premarket notification filed by Beijing Lead Beauty S & T Co., Ltd with the FDA for Q Switched Nd: Yag Laser Machine.

Pre-market Notification Details

Device IDK193609
510k NumberK193609
Device Name:Q Switched Nd: YAG Laser Machine
ClassificationPowered Laser Surgical Instrument
Applicant Beijing Lead Beauty S & T Co., Ltd 202, No.5 Workshop, No.1 Caida 3rd Road Nancai Shunyi District Beijing,  CN 101300
ContactJiao Zhang
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai,  CN 200120
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-03-20

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