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VS3-IR-MMS System

by Visionsense Ltd.

510(k) K150018

VS3-IR-MMS System is a medical device (FDA Class II; FDA product code OWN, Confocal Optical Imaging) made by Visionsense Ltd., cleared under FDA 510(k) K150018 on 17 Jun 2015, active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150018 Date17 Jun 2015ClearedStatusActive

Official records

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0280-2023 FDA Class II initiated 17 Oct 2022
    • Ongoing Z-0282-2023 FDA Class II initiated 17 Oct 2022

    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.

    • Ongoing Z-0281-2023 FDA Class II initiated 17 Oct 2022

    XXX

Timeline

4 dated events

  1. Cleared FDA 510(k) K150018
  2. Recall initiated FDA recalls Z-0280-2023
  3. Recall initiated FDA recalls Z-0282-2023
  4. Recall initiated FDA recalls Z-0281-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OWN
FDA applicant
Visionsense, Ltd.
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code OWN (Confocal Optical Imaging).

Other devices from Visionsense Ltd.

See all devices from Visionsense Ltd. →