# K831231: Led Goggles

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Laboratories, Inc.
- Decided: May 16, 1983 after 31 days
- Product code: HLX (Photostimulator, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

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

Source page: https://510kreport.com/device/K831231
Methodology: https://510kreport.com/methodology