# K101763: Diopsys Nova Vep Vision Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Diopsys, Inc.
- Decided: May 9, 2011 after 320 days
- Product code: GWE (Stimulator, Photic, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K760199 (1976). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043491: Enfanttm, Diopsys, Inc. (2005) Summary page 1.
- K081591: Neucodia, Verisci Corporation (2009) Summary page 1.

## Indications for use
The NOVA is an electrophysiological device that generates photic stimuli, and records, processes, and analyzes the resultant visual evoked potential (VEP) signals to provide information about the visual system structural and neural abnormalities.

Source page: https://510kreport.com/device/K101763
Methodology: https://510kreport.com/methodology