Chrysalis Intelligence · Sponsors · Visionsense, Ltd.

Visionsense, Ltd.

Petach Tikva, Hamerkaz, IL · 2 510(k) clearances · 3 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
2
2021-11-22 → 2022-10-28
Last 12 months
0
Product codes
1
Most recent
2022-10-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OWN Confocal Optical Imaging Class II Gastroenterology, Urology 2 2022-10-28
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
3
Most recent
2022-10-17
DateSeverityStatusRecall # ProductCodeReason
2022-10-17 Class II Ongoing Z-0282-2023 VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001 — Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
2022-10-17 Class II Ongoing Z-0281-2023 VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012 — XXX
2022-10-17 Class II Ongoing Z-0280-2023 VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012 — Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2022-10-28 K223020 VS3-Iridium System (VS3-IR) OWN Class II Gastroenterology, Urology
2021-11-22 K210265 VS3 Iridium Sytem OWN Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence