# K022373: Chromagen V3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lens

- Pathway: 510(k) (Traditional)
- Applicant: Cantor & Nissel, Ltd.
- Decided: Oct 7, 2002 after 77 days
- Product code: NJH (Lens, Spectacle (Prescription), For Reading Discomfort)
- Device class: 1
- Regulation: 21 CFR 886.5844
- 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 K990757 (1999). 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)
- K012132: Chromagen V3.0 Reading Aid Soft Contact Lens, Cantor & Nissel, Ltd. (2002) Summary page 3.
- K994320: Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact Lenses, Cantor & Silver, Ltd. (2000) Summary page 1.

## Indications for use
Prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.

Source page: https://510kreport.com/device/K022373
Methodology: https://510kreport.com/methodology