Laser Therapy Device

Powered Laser Surgical Instrument

Shenzhen Leaflife Technology Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Leaflife Technology Co., Ltd with the FDA for Laser Therapy Device.

Pre-market Notification Details

Device IDK202980
510k NumberK202980
Device Name:Laser Therapy Device
ClassificationPowered Laser Surgical Instrument
Applicant Shenzhen Leaflife Technology Co., Ltd Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen,  CN 518116
ContactCheng Qiang
CorrespondentAlbert Ou
Shenzhen Leaflife Technology Co., Ltd Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen,  CN 518116
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2020-11-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06974223650011 K202980 000

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