510(k) · Cleared
ClearedCiba Vision (Nelfilcon a) One-Day Soft Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Corporation · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 14, 2009 as substantially equivalent to K050065 (Ciba Vision Corporation, 2005) and 1 other predicate after a 165-day review. Its family tree reaches back 4 generations to 1983. 10 later devices descend from it.
- Decided
- Apr 14, 2009
- Review
- 165 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P820021 (1983). 11 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
- 3 generations backK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
- 2 generations backK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
- 1 generation backK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
- This deviceK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
- Descendant · cites it directly · 7 of its ownK153643 Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK180398 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK181454 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech…Alcon Laboratories, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK180669 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK123994 Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies…Ciba Vision Corporation · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K153643Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. · 2016 · cites it directly7descendants
- K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc. · 2018 · 2 generations on4descendants
- K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus…Alcon Laboratories, Inc. · 2018 · 3 generations on2descendants
- K180669Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc. · 2018 · 2 generations on2descendants
- K123994Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus…Ciba Vision Corporation · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P820021 | Softcon (Vifilcon a) Soft Contact Ext Wear Lens | Alcon Laboratories, Inc. | 1983 | — |
| −3 | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens | Ciba Vision Corporation | 1996 | 1 |
| −2 | K992446 | Dailies (Nelfilcon a) One-Day | Ciba Vision Johns Creek Mfg. | 1999 | — |
| −1 | K050213 | Freshlook One-Day Color Contact Lens | Ciba Vision Corporation | 2005 | — |
| 0 (this device) | K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | Ciba Vision Corporation | 2009 | — |
| +1 | 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 | — |
| +3 | K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES… | Alcon Laboratories, Inc. | 2018 | — |
| +2 | K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES… | Alcon Laboratories, Inc. | 2018 | — |
| +1 | K123994 | Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort… | Ciba Vision Corporation | 2013 | — |
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 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 LPL? 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 LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 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 |
|---|---|---|---|
| * | K050065 | Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesSummary page 1…ce: Predicate devices are: 1) Focus® DAILIES®, Focus® DAILIES® Toric, and Focus® DAILIES® Progressives (nelfilcon A) One-Day Contact Lenses, as cleared under K050065, 2) FreshLook®, FreshLook® Toric, and FreshLook® Progressives (nelfilcon A) One-Day Color Contact Lens, as cleared under… | 2005 |
| * | K050213 | Freshlook One-Day Color Contact LensSummary page 1…Contact Lenses, as cleared under K050065, 2) FreshLook®, FreshLook® Toric, and FreshLook® Progressives (nelfilcon A) One-Day Color Contact Lens, as cleared under K050213. 4. Description of Device: The lens material is 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetal… | 2005 |
What descends from it? (10)
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K153643 (Alcon Laboratories, Inc., 2016) has gone furthest, with 7 descendants of its own.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, 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 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 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 non-diseased eyes. Focus® DAILIES® Progressives (nelfilcon 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…
Read the full statement (123 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 non-diseased eyes.
Focus® DAILIES® Progressives (nelfilcon 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 +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 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/K083216 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083216: Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083216
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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