# K120104: Visionsearch 1

- Pathway: 510(k) (Traditional)
- Applicant: Visionsearch Pty, Ltd.
- Decided: May 21, 2012 after 129 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: 2 generations back to K863956 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023525: Retiscan, Retiport, Roland Consult (2004) Summary page 2.

## Indications for use
Electrophysiologictal Test Unit for quantifying the response to visual stimulation by measuring the Visual Evoked Potential.

Source page: https://510kreport.com/device/K120104
Methodology: https://510kreport.com/methodology