# VS3-IR-MMS System

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/vs3-ir-mms-system-own>
- Manufacturer: [Visionsense Ltd.](https://devicerts.com/manufacturers/visionsense-ltd) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: OWN

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K150018 · decision 2015-06-17 · decision SESE · status: Active

## Recalls

- Z-0280-2023 · Class II · ongoing · initiated 2022-10-17: 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.
- Z-0282-2023 · Class II · ongoing · initiated 2022-10-17: 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.
- Z-0281-2023 · Class II · ongoing · initiated 2022-10-17: XXX

## Identifiers

- 510(k) Number: K150018 [FDA 510(k)]
- FDA product code: OWN [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 876.1500 [FDA 510(k)]
- Advisory committee: Gastroenterology, Urology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: VS3-IR-MMS System, Visionsense Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/vs3-ir-mms-system-own (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/vs3-ir-mms-system-own.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/vs3-ir-mms-system-own
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.