DIODE LASER HAIR REMOVAL SYSTEM

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 Hair Removal System.

Pre-market Notification Details

Device IDK142186
510k NumberK142186
Device Name:DIODE LASER HAIR REMOVAL SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant SHENZHEN GSD TECH. CO., LTD. P.O. BOX 120-119 Shanghai,  CN 200120
ContactDiana Hong
CorrespondentDiana Hong
SHENZHEN GSD TECH. 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 Received2014-08-08
Decision Date2015-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06928258000914 K142186 000
06928258000907 K142186 000

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