GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

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 Gsd Intense Pulsed Light System, Models: Gp666c4, Gp666c.

Pre-market Notification Details

Device IDK091664
510k NumberK091664
Device Name:GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
Applicant SHENZHEN GSD TECH. CO., LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai,  CN 200030
ContactDiana Hong
CorrespondentDiana Hong
SHENZHEN GSD TECH. CO., LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai,  CN 200030
Product CodeONF  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-09
Decision Date2009-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06928258000891 K091664 000

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