510(k) · Cleared
ClearedChromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cantor & Silver, Ltd. · NCZ Lens, Contact, For Color Vision Deficiency
Cleared on Oct 20, 2000 after a 303-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Oct 20, 2000
- Review
- 303 days
- Class
- Class II
- Product code
- NCZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK994320 Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft…Cantor & Silver, Ltd. · 2000
- Descendant · cites it directly · 1 of its ownK012132 Chromagen V3.0 Reading Aid Soft Contact LensCantor & Nissel, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK022373 Chromagen V3.0 Reading Aid & Color Discrimination Enhancement…Cantor & Nissel, Ltd. · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994320 | Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact Lenses | Cantor & Silver, Ltd. | 2000 | — |
| +1 | K012132 | Chromagen V3.0 Reading Aid Soft Contact Lens | Cantor & Nissel, Ltd. | 2002 | — |
| +1 | K022373 | Chromagen V3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lens | Cantor & Nissel, Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NCZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | “X-Chrom” RED Tinted PMMA Contact Lens Named without a submission number | |
| * | — | Cantor & Silver “CANTOR & SILVER 5X Tinted” Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012132 (Cantor & Nissel, Ltd., 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NCZ devicesNCZ Lens, Contact, For Color Vision Deficiency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NCZ
FDA has decided no NCZ device since 2007.
Median 510(k) review, days · NCZ
Too few NCZ 510(k)s in any year since 2007 to give a median.
Recalls per year · NCZ
No recall names NCZ since 2007.
Adverse event reports per year · NCZ
1in 2019
MAUDE reports naming product code NCZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994320 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994320: Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994320
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026