# K011794: Xltek Led Goggles, Model Led-01

- Pathway: 510(k) (Traditional)
- Applicant: Excel Tech., Ltd.
- Decided: Oct 1, 2001 after 115 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: 1 generation back to K010092 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010092: Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed), Excel Tech., Ltd. (2001) Summary page 1.
- (no number) Grass-Telefactor LED Goggles: named in the summary without a submission number

## Most influential descendants
- K113785: Adherent Visual Stimulator Goggles (2012), 1 descendant of its own
- K200705: Nurochek System (2020), 0 descendants of its own

## Indications for use
The LED Visual Stimulator Goggles are intended to flash visible light into a patient’s eyes. The LED Visual Stimulator Goggles are designed to be used in hospital and clinical settings by trained medical personnel.

Source page: https://510kreport.com/device/K011794
Methodology: https://510kreport.com/methodology