Visionsense, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
13
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0280-2023Class IIVS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: October 17, 2022
Z-0282-2023Class IIVS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product NumbeOctober 17, 2022
Z-0281-2023Class IIVS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product NumOctober 17, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K223020VS3-Iridium System (VS3-IR)October 28, 2022
K210265VS3 Iridium SytemNovember 22, 2021
K171208Trans-anal IntroducerFebruary 5, 2018
K153548VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEMFebruary 22, 2016
K152204VS3-IR systemOctober 28, 2015
K150018VS3-IR-MMS SystemJune 17, 2015
K141002VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEMJune 26, 2014
K131434VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEMJuly 16, 2013
K123467VS3April 17, 2013
K082355VISIONSENSE STEREOSCOPIC VISION SYSTEMDecember 15, 2008
K082667VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)October 30, 2008
K081102VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEMMay 29, 2008
K073279VS-VISIONSENSE STEREOSCOPIC VISION SYSTEMMarch 5, 2008