Diode Laser System GP900A8, Diode Laser System GP900Q8

Powered Laser Surgical Instrument

Shenzhen GSD Tech Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Gsd Tech Co., Ltd. with the FDA for Diode Laser System Gp900a8, Diode Laser System Gp900q8.

Pre-market Notification Details

Device IDK213225
510k NumberK213225
Device Name:Diode Laser System GP900A8, Diode Laser System GP900Q8
ClassificationPowered Laser Surgical Instrument
Applicant Shenzhen GSD Tech Co., Ltd. Building A, JUNSD Hi-Tech Park, West Of Bao’An RD. Watch & Clock Base, Guangming District Shenzhen,  CN 518106
ContactHuifang Yao
CorrespondentHuifang Yao
Shenzhen GSD Tech Co., Ltd. Building A, JUNSD Hi-Tech Park, West Of Bao’An RD. Watch & Clock Base, Guangming District Shenzhen,  CN 518106
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-29
Decision Date2021-12-22

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