510(k) · Cleared
ClearedFreshlook One-Day Color Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Corporation · MVN Lens, Contact, (Disposable)
Cleared on Mar 28, 2005 as substantially equivalent to K963487 (Ciba Vision Corporation, 1996) and 5 other predicates after a 56-day review. Its family tree reaches back 3 generations to 1983. 21 later devices descend from it.
- Decided
- Mar 28, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to P820021 (1983). 8 ancestors in all. 21 later devices descend from it, 5 citing it directly.
- Root · 3 generations backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
- 2 generations backK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
- 1 generation backK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
- This deviceK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
- Descendant · cites it directly · 10 of its ownK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
- Descendant · cites it directly · 8 of its ownK123484 Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal…St. shine Optical Co., Ltd. · 2013
- Descendant · 2 generations on · 7 of its ownK162317 Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact…St. shine Optical Co., Ltd. · 2016
- Descendant · 2 generations on · 7 of its ownK153643 Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009 · cites it directly10descendants
- K123484Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft…St. shine Optical Co., Ltd. · 2013 · cites it directly8descendants
- K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors…St. shine Optical Co., Ltd. · 2016 · 2 generations on7descendants
- K153643Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. · 2016 · 2 generations on7descendants
- K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P820021 | Softcon (Vifilcon a) Soft Contact Ext Wear Lens | Alcon Laboratories, Inc. | 1983 | — |
| −2 | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens | Ciba Vision Corporation | 1996 | 1 |
| −1 | K992446 | Dailies (Nelfilcon a) One-Day | Ciba Vision Johns Creek Mfg. | 1999 | — |
| 0 (this device) | K050213 | Freshlook One-Day Color Contact Lens | Ciba Vision Corporation | 2005 | — |
| +1 | K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | Ciba Vision Corporation | 2009 | — |
| +1 | K123484 | Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon… | St. shine Optical Co., Ltd. | 2013 | — |
| +2 | K162317 | Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens… | St. shine Optical Co., Ltd. | 2016 | — |
| +2 | K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | Alcon Laboratories, Inc. | 2016 | — |
| +3 | K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact… | Pegavision Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 reading of the summary gave 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…s® DAILIES® (nelfilcon A)One Day Contact Lens Clear lenses (spherical & toric): K943487 VlSITINT® lenses: K984273 Manufacturing Change-Surfactant Additive: K010636 Multifocal Design: CIBA Vision's Focus® DAILIES® Progressiv… | 1999 |
| * | K010636 | Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus Dailies Progressives…Summary page 1…enses (spherical & toric): K943487 VlSITINT® lenses: K984273 Manufacturing Change-Surfactant Additive: K010636 Multifocal Design: CIBA Vision's Focus® DAILIES® Progressives (nelfilcon A)One Day Visitint lenses:… | 2001 |
| * | K003826 | Focus Dailies ProgressivesSummary page 1…rfactant Additive: K010636 Multifocal Design: CIBA Vision's Focus® DAILIES® Progressives (nelfilcon A)One Day Visitint lenses: K003826 Print Process/Use of Color Additives: FreshLook® (phemfilcon A) soft P830037 contact… | 2001 |
| * | K992446 | Dailies (Nelfilcon a) One-DaySummary page 3…ilization method and cycle remain unchanged from the descriptions previously provided in cleared Premarket Notifications 510(k) K963487, K984273, K992446, K003826, K010636. * Lens Design: No change to established spherical, toric or multi-focal lens designs. =… | 1999 |
| * | P830037 | Durasoft (R) 3 for Ext WearSummary page 1…ne Day Visitint lenses: K003826 Print Process/Use of Color Additives: FreshLook® (phemfilcon A) soft P830037 contact lenses CIBA Vision® Corporation Page 2of… | 1984 |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | 2009 | 10 |
| K123484 | Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft… | 2013 | 8 |
| K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort… | 2018 | 4 |
| K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort… | 2018 | 2 |
| K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives | 2019 | 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K083216 (Ciba Vision Corporation, 2009) has gone furthest, with 10 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?
FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye. FreshLook® Progressives (nelfilcon A) One Day Color Contact…
Read the full statement (177 words)
FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
FreshLook® Progressives (nelfilcon A) One Day Color 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 +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity. The FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
The FreshLook® (nelfilcon A) One Day Color 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/K050213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050213: Freshlook One-Day Color 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/K050213
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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