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Vestibular First

FDA UDI

Class II (US FDA UDI)

by Vestibular First

Identity

Trade Name
Vestibular First FDA UDI
Generic Name
Eye/eyelid movement monitoring spectacles/goggles FDA UDI
Device Name
The Insight Infrared Video Goggles Pro+ are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age. FDA UDI
Model / Reference
Insight Infrared Video Goggles Pro+ FDA UDI
Description
The Insight Infrared Video Goggles Pro+ are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age. FDA UDI

Identifiers

Catalog Number
INSIGHT-PRO-PLUS FDA UDI
Primary DI / UDI-DI
00860002280745 FDA UDI
510(k) Number
K203082 FDA UDI
FDA Product Code
GWN FDA UDI
GMDN Term
Eye/eyelid movement monitoring spectacles/goggles FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1460 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Eye/eyelid movement monitoring spectacles/goggles

Vestibular First by Vestibular First — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eye/eyelid movement monitoring spectacles/goggles.

Cleared under the same submission

K203082 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vestibular First

Sources (1)

  • FDA UDI 01b36f71-eced-48dc-86e9-38f83b37d201 37 fields · synced May 30, 2026