510(k) · Cleared
ClearedFocus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · MVN Lens, Contact, (Disposable)
Cleared on Aug 21, 2020 as substantially equivalent to K180669 (Alcon Laboratories, Inc., 2018) and 1 other predicate after a 29-day review. Its family tree reaches back 8 generations to 1983.
- Decided
- Aug 21, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to P820021 (1983). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
- 7 generations backK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
- 6 generations backK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
- 5 generations backK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
- 4 generations backK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
- 3 generations backK153643 Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. · 2016
- 2 generations backK180398 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2018
- 1 generation backK181454 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech…Alcon Laboratories, Inc. · 2018
- This deviceK202036 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | P820021 | Softcon (Vifilcon a) Soft Contact Ext Wear Lens | Alcon Laboratories, Inc. | 1983 | — |
| −7 | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens | Ciba Vision Corporation | 1996 | 1 |
| −6 | K992446 | Dailies (Nelfilcon a) One-Day | Ciba Vision Johns Creek Mfg. | 1999 | — |
| −5 | K050213 | Freshlook One-Day Color Contact Lens | Ciba Vision Corporation | 2005 | — |
| −4 | K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | Ciba Vision Corporation | 2009 | — |
| −3 | K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | Alcon Laboratories, Inc. | 2016 | — |
| −2 | K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES… | Alcon Laboratories, Inc. | 2018 | — |
| −1 | K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES… | Alcon Laboratories, Inc. | 2018 | — |
| 0 (this device) | K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES… | Alcon Laboratories, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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
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 |
|---|---|---|---|
| * | K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Summary page 5…Plus family (nelfilcon A) soft contact lenses, which are legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K180669 and K181454. IV. Device Description Focus DAILIES and DAILIES AquaComfort Plus are soft contact lenses, intended for… | 2018 |
| * | K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus…Summary page 5…(nelfilcon A) soft contact lenses, which are legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K180669 and K181454. IV. Device Description Focus DAILIES and DAILIES AquaComfort Plus are soft contact lenses, intended for the op… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 23 ancestors have a recall of any class.
- 1 other device also cites its predicate K180669.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes. Focus DAILIES Progressives (nellcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with…
Read the full statement (312 words)
Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.
Focus DAILIES Progressives (nellcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +300 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with Visual acuity.
The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus Toric (nellcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES AquaComfort Plus Multifocal (nelfllcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +300 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with Visual acuity.
All DAILIES AquaComfort Plus (nellcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202036 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202036: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202036
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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