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Ics Medical Model VG-30 Video Goggles

by Ics Medical

510(k) K013060

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013060 Date10 Dec 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
GWN
Device Class
Class II
Regulation
21 CFR Part 882.1460
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ics Medical Model VG-30 Video Goggles are a nystagmograph that incorporates two infrared‑illuminated cameras mounted in a face‑worn housing to capture video of a patient’s eyes. The system provides real‑time video signals that allow clinicians to observe, record, and measure eye movements during vestibular function testing.

The device is supplied as a complete, reusable unit for clinical use and is regulated as a Class II medical device. It received traditional FDA 510(k) clearance (K013060) on 10 December 2001 under product code GWN, with a designation of “Substantially Equivalent.”

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