# K992473: Expresseye

- Pathway: 510(k) (Traditional)
- Applicant: Optomotor Laboratories
- Decided: Aug 12, 1999 after 17 days
- Product code: GWN (Nystagmograph)
- Device class: 2
- Regulation: 21 CFR 882.1460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) House Infrared/Video Electronystagmograph System by Eye Dynamics, Inc.: named in the summary without a submission number

## Indications for use
ExpressEye can be used in any case of problems in the optomotor domain. The measured horizontal eye movements of a person made in response to generated stimuli are analysed to determine several parameters of the person's fixation and reflexive and voluntary eye movement control.

Source page: https://510kreport.com/device/K992473
Methodology: https://510kreport.com/methodology