VS3-IR System

Confocal Optical Imaging

VISIONSENSE LTD

The following data is part of a premarket notification filed by Visionsense Ltd with the FDA for Vs3-ir System.

Pre-market Notification Details

Device IDK152204
510k NumberK152204
Device Name:VS3-IR System
ClassificationConfocal Optical Imaging
Applicant VISIONSENSE LTD 20 HAMAGSHIMIM ST Petach Tikva, Hamerkaz,  IL 49348
ContactAlex Chanin
CorrespondentRaymond Kelly
LICENSALE INC 57 LAZY BROOK RD Monroe,  CT  06468
Product CodeOWN  
Subsequent Product CodeGCJ
Subsequent Product CodeGWG
Subsequent Product CodeHRX
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2015-08-06
Decision Date2015-10-28
Summary:summary

NIH GUDID Devices

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