VS3-Iridium System (VS3-IR)

Confocal Optical Imaging

Visionsense Ltd.

The following data is part of a premarket notification filed by Visionsense Ltd. with the FDA for Vs3-iridium System (vs3-ir).

Pre-market Notification Details

Device IDK223020
510k NumberK223020
Device Name:VS3-Iridium System (VS3-IR)
ClassificationConfocal Optical Imaging
Applicant Visionsense Ltd. 20 Hamagshimim St. Petach Tikva, Hamerkaz,  IL 4934829
ContactGuy Wroclawski
CorrespondentGuy Wroclawski
Visionsense Ltd. 20 Hamagshimim St. Petach Tikva, Hamerkaz,  IL 4934829
Product CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-29
Decision Date2022-10-28

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