# K113785: Adherent Visual Stimulator Goggles

- Pathway: 510(k) (Traditional)
- Applicant: Anschel Technology, Inc.
- Decided: Jun 6, 2012 after 166 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 K010092 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831231: Led Goggles, Cadwell Laboratories, Inc. (1983) Summary page 2.
- K011794: Xltek Led Goggles, Model Led-01, Excel Tech., Ltd. (2001) Summary page 2.

## Most influential descendants
- K200705: Nurochek System (2020), 0 descendants of its own

## Indications for use
The SightSaver™ is an evoked response photic stimulator that is used to apply a visible light stimulus to a patient's eyes for use in evoked response measurements or for electroencephalogram (EEG) activation. The SightSaver™ Visual Stimulator is designed to be used in hospital and clinical settings by trained medical personnel and is for prescription use only.

Source page: https://510kreport.com/device/K113785
Methodology: https://510kreport.com/methodology