510(k) · Cleared
ClearedDailies (Nelfilcon a) One-Day
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Johns Creek Mfg. · MVN Lens, Contact, (Disposable)
Cleared on Aug 18, 1999 as substantially equivalent to K963487 (Ciba Vision Corporation, 1996) and 1 other predicate after a 27-day review. Its family tree reaches back 2 generations to 1983. 22 later devices descend from it.
- Decided
- Aug 18, 1999
- Review
- 27 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P820021 (1983). 4 ancestors in all. 22 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
- 1 generation backK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
- This deviceK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
- Descendant · cites it directly · 21 of its ownK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
- Descendant · 2 generations on · 10 of its ownK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
- Descendant · 2 generations on · 8 of its ownK123484 Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal…St. shine Optical Co., Ltd. · 2013
- Descendant · 3 generations on · 7 of its ownK162317 Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact…St. shine Optical Co., Ltd. · 2016
- Descendant · 3 generations on · 7 of its ownK153643 Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. · 2016
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K050213Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005 · cites it directly21descendants
- K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009 · 2 generations on10descendants
- K123484Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft…St. shine Optical Co., Ltd. · 2013 · 2 generations on8descendants
- K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors…St. shine Optical Co., Ltd. · 2016 · 3 generations on7descendants
- K153643Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. · 2016 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P820021 | Softcon (Vifilcon a) Soft Contact Ext Wear Lens | Alcon Laboratories, Inc. | 1983 | — |
| −1 | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens | Ciba Vision Corporation | 1996 | 1 |
| 0 (this device) | K992446 | Dailies (Nelfilcon a) One-Day | Ciba Vision Johns Creek Mfg. | 1999 | — |
| +1 | K050213 | Freshlook One-Day Color Contact Lens | Ciba Vision Corporation | 2005 | — |
| +2 | K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | Ciba Vision Corporation | 2009 | — |
| +2 | K123484 | Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon… | St. shine Optical Co., Ltd. | 2013 | — |
| +3 | K162317 | Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens… | St. shine Optical Co., Ltd. | 2016 | — |
| +3 | K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | Alcon Laboratories, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 MVN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MVN device
- #1 K261812 HOYA Illumina (sorafilcon A) Daily Disposable…score 14.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens Our OCR of the scanned summary read K943487, FDA’s number for BIO74-PF Crown & Bridge Alloy (Jeneric/Pentron, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CIBA Vision's Focus® DAILIES® (nelfilcon A) One-Day Contact Lens —…”. | 1996 |
| * | K984273 | Focus Dailies Visitint (Nelfilcon a) One-Day Contact LensSummary page 1…n: Class Il {21 CFR 886.5925 (b) (1)} 3. Predicate Device(s): CIBA Vision's Focus® DAILIES® (nelfilcon A) One-Day Contact Lens Clear lenses: K943487 VISITINT® lenses: K984273 4. Description of Device: The DAILIES® (nelfilcon A) ONE-DAY CONTACT LENS is a daily wear soft contact lens intended for single… | 1999 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050213 | Freshlook One-Day Color Contact Lens | 2005 | 21 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K050213 (Ciba Vision Corporation, 2005) has gone furthest, with 21 descendants of its own.
- 5 other devices also cite its predicate K963487.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MVN
Too few MVN 510(k)s in any year since 2007 to give a median.
Recalls per year · MVN
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVN
22in 2025
MAUDE reports naming product code MVN, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 1 | — | 2 | 35 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 2 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 23 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 2 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Focus® DAILIES® (nelfilcon A) One-Day contact lens is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not aphakic persons with non-diseased eyes.
Eye care practitioners may prescribe the lens for single-use daily disposable wear. DAILIES (nelfilcon A) lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
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/K992446 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992446: Dailies (Nelfilcon a) One-Day.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992446
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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