# K012132: Chromagen V3.0 Reading Aid Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Cantor & Nissel, Ltd.
- Decided: May 9, 2002 after 304 days
- Product code: NIC (Lens, Contact, For Reading Discomfort)
- Device class: 2
- Regulation: 21 CFR 886.5925
- 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 K990757 (1999). 2 ancestors in all.
1 later device descends 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)
- K990757: Cantor & Silver 5X Tinted (Hioxifilcon a) Soft (Spherical & Toric) Daily Wear Contact Wear Contact Lens, Tinted (Transpa, Cantor & Silver, Ltd. (1999) Summary page 1.
- K994320: Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact Lenses, Cantor & Silver, Ltd. (2000) Summary page 1.

## Most influential descendants
- K022373: Chromagen V3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lens (2002), 0 descendants of its own

## Indications for use
The ChromaGen vso Reading Aid Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. Theses lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.

Source page: https://510kreport.com/device/K012132
Methodology: https://510kreport.com/methodology