Visionsense, Ltd.

Medical device manufacturer in Petach Tikva, Hamerkaz, IL.

13510(k) clearances
0PMA approvals
4recalls

Device types

510(k) clearances

510(k)DeviceDecision
K223020VS3-Iridium System (VS3-IR)OWN · Special 10/28/2022SE
K210265VS3 Iridium SytemOWN · Traditional 11/22/2021SE
K171208Trans-anal IntroducerFED · Traditional 02/05/2018SE
K153548VS3 Stereoscopic High Definition Vision SystemHRX · Traditional 02/22/2016SE
K152204VS3-IR systemOWN · Traditional 10/28/2015SE
K150018VS3-IR-MMS SystemOWN · Traditional 06/17/2015SE
K141002VS3 Stereoscopic High Definition Vision SystemHRX · Traditional 06/26/2014SE
K131434VS3 Stereoscopic High Definition Vision SystemGWG · Special 07/16/2013SE
K123467VS3GCJ · Special 04/17/2013SE
K082355Visionsense Stereoscopic Vision SystemHRX · Traditional 12/15/2008SE
K082667Visionsense Stereoscopic Vision System (VS System)EOB · Traditional 10/30/2008SE
K081102Vsu - Visionsense Stereoscopic Vision SystemGWG · Traditional 05/29/2008SE
K073279Vs-Visionsense Stereoscopic Vision SystemGCJ · Special 03/05/2008SE

Recalls

RecallProductInitiated
Z-0282-2023 Class IIVS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner)…Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of… 10/17/2022Open, Classified
Z-0281-2023 Class IIVS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm…XXX 10/17/2022Open, Classified
Z-0280-2023 Class IIVS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product…Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of… 10/17/2022Open, Classified
Z-1192-2012 Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and…A complaint was received and a unit returned that exhibited the metal and glass shaft window becoming… 03/21/2011Terminated