Eye-Sync
by Syncthink, Inc. 510(k)
Active
510(k) K152915
Overview
Eye-Sync is a nystagmograph device designed to objectively measure eye movement. It utilizes eye-tracking technology to assess brain function and performance.
This device is a Class 2 medical device regulated under 21 CFR 882.1460. It has received FDA 510(k) clearance through a traditional submission process.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152915 | Date29 Jan 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from Syncthink, Inc.
Questions
What is the primary function of the Eye-Sync device?
Eye-Sync is a nystagmograph designed to objectively measure eye movement. It utilizes specialized eye-tracking technology to provide data that assists in the assessment of brain function and performance.
How is the Eye-Sync device regulated?
The Eye-Sync is classified as a Class 2 medical device under 21 CFR 882.1460. It has received FDA 510(k) clearance through a traditional submission process under the product code GWN.
Which medical specialty is associated with this device?
The Eye-Sync device is categorized under the neurology medical specialty. This reflects its intended use in measuring eye movements to evaluate neurological function and performance.