510(k) · Cleared
ClearedChromagen V3.0 Reading Aid Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cantor & Nissel, Ltd. · NIC Lens, Contact, For Reading Discomfort
Cleared on May 9, 2002 as substantially equivalent to K990757 (Cantor & Silver, Ltd., 1999) and 1 other predicate after a 304-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- May 9, 2002
- Review
- 304 days
- Class
- Class II
- Product code
- NIC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K990757 (1999). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK990757 Cantor & Silver 5X Tinted (Hioxifilcon a) Soft (Spherical & Toric)…Cantor & Silver, Ltd. · 1999
- This deviceK012132 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 1 of 1 · See all- K022373Chromagen V3.0 Reading Aid & Color Discrimination Enhancement Spectacle LensCantor & Nissel, Ltd. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990757 | Cantor & Silver 5X Tinted (Hioxifilcon a) Soft (Spherical & Toric) Daily Wear… | Cantor & Silver, Ltd. | 1999 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 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 NIC? 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 |
|---|---|---|---|
| * | K990757 | Cantor & Silver 5X Tinted (Hioxifilcon a) Soft (Spherical & Toric) Daily Wear Contact…Summary page 1…ice Classification: Class H Classification Number: Y, 525 Trade Name: ChromaGen vs ¢ Reading Aid Soft Contact Lens Reasonvfor 510(k) submission: Expanded Indication to K990757, K994320 Classification Name: Lens, Soft Contact, Daily Wear Substantially Equivalent Devices: The ChromaGen vs… | 1999 |
| * | K994320 | Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact LensesSummary page 1…ification: Class H Classification Number: Y, 525 Trade Name: ChromaGen vs ¢ Reading Aid Soft Contact Lens Reasonvfor 510(k) submission: Expanded Indication to K990757, K994320 Classification Name: Lens, Soft Contact, Daily Wear Substantially Equivalent Devices: The ChromaGen vsq Reading… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022373 | Chromagen V3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lens | 2002 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K022373 (Cantor & Nissel, Ltd., 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NIC devicesNIC Lens, Contact, For Reading Discomfort: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIC
FDA has decided no NIC device since 2007.
Median 510(k) review, days · NIC
Too few NIC 510(k)s in any year since 2007 to give a median.
Recalls per year · NIC
No recall names NIC since 2007.
Adverse event reports per year · NIC
No MAUDE report names NIC since 2007.
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 | 0 |
| 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 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.
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/K012132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012132: Chromagen V3.0 Reading Aid Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012132
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026