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Eye-Sync

FDA UDI

Class II (US FDA UDI)

by Neurosync, Inc.

Identity

Trade Name
EYE-SYNC FDA UDI
Generic Name
Vision physiology/eye movement analysis system FDA UDI
Device Name
The NeuroSync EYE-SYNC device is a portable, fully enclosed eye tracking environment with two primary components: 1. Eye Tracker (head-mounted device) with eye tracking sensor and display 2. Android Tablet The eye tracker is a Pico Neo 3 Pro Eye with embedded sensors provided by Tobii Tech. It is mounted to the subject's face and held in place using a strap. The eye tracking sensor includes two cameras (one for each eye) to capture eye movement data. Eye gaze tracking is performed using a proprietary implementation of the pupil-corneal reaction method. The integrated display within the headset provides a binocular visual field and operates as part of the standalone VR system, running on Qualcomm Snapdragon XR2 hardware. The headset processes eye-tracking data internally and supports USB-C connectivity. The display receives eye tracking sensor information for post-processing, manages sensor calibration, provides binocular visual display to the subject, and interfaces with the Android tablet over Bluetooth. Eye gaze tracking and visual display is combined to provide several assessment paradigms to characterize subject eye tracking performance. FDA UDI
Model / Reference
X03 FDA UDI
Description
The NeuroSync EYE-SYNC device is a portable, fully enclosed eye tracking environment with two primary components: 1. Eye Tracker (head-mounted device) with eye tracking sensor and display 2. Android Tablet The eye tracker is a Pico Neo 3 Pro Eye with embedded sensors provided by Tobii Tech. It is mounted to the subject's face and held in place using a strap. The eye tracking sensor includes two cameras (one for each eye) to capture eye movement data. Eye gaze tracking is performed using a proprietary implementation of the pupil-corneal reaction method. The integrated display within the headset provides a binocular visual field and operates as part of the standalone VR system, running on Qualcomm Snapdragon XR2 hardware. The headset processes eye-tracking data internally and supports USB-C connectivity. The display receives eye tracking sensor information for post-processing, manages sensor calibration, provides binocular visual display to the subject, and interfaces with the Android tablet over Bluetooth. Eye gaze tracking and visual display is combined to provide several assessment paradigms to characterize subject eye tracking performance. FDA UDI

Identifiers

Primary DI / UDI-DI
00860013612900 FDA UDI
510(k) Number
K152915 FDA UDI
K202927 FDA UDI
FDA Product Code
GWN FDA UDI
QEA FDA UDI
GMDN Term
Vision physiology/eye movement analysis system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1460 FDA UDI
882.1455 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

No

FDA UDI

Category: Vision physiology/eye movement analysis systemEye-tracking neurological/brain injury assessment device

Eye-Sync by Neurosync, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eye-tracking neurological/brain injury assessment device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurosync, Inc.

Sources (1)

  • FDA UDI 05460b30-585c-40ec-8fc3-9b97e2e02cd5 35 fields · synced May 30, 2026