# K994320: Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Cantor & Silver, Ltd.
- Decided: Oct 20, 2000 after 303 days
- Product code: NCZ (Lens, Contact, For Color Vision Deficiency)
- 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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. The FDA summary names its predicate without a number.
- (no number) “X-Chrom” RED Tinted PMMA Contact Lens: named in the summary without a submission number
- (no number) Cantor & Silver “CANTOR & SILVER 5X Tinted”: named in the summary without a submission number

## Most influential descendants
- K012132: Chromagen V3.0 Reading Aid Soft Contact Lens (2002), 1 descendant of its own
- K022373: Chromagen V3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lens (2002), 0 descendants of its own

## Indications for use
The ChromaGen v, Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses are indicated for daily wear to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes. 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/K994320
Methodology: https://510kreport.com/methodology