510(k) Report

510(k) · Cleared

Recalled · 2003

Dailies (Nelfilcon a) One-Day Soft Contact Lens

K963487510(k) TraditionalCleared Nov 27, 199685-day reviewClass II21 CFR 886.5925Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ciba Vision Corporation · LPL Lenses, Soft Contact, Daily Wear

Cleared on Nov 27, 1996 as substantially equivalent to P820021 (Alcon Laboratories, Inc., 1983) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1983. 26 later devices descend from it. It has been recalled once.

Decided
Nov 27, 1996
Review
85 days
Class
Class II
Product code
LPL
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to P820021 (1983). 2 ancestors in all. 26 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1989: 1 other ancestor2005: 2 descendants cleared1999: 1 descendant cleared2003: 1 descendant cleared2018: 4 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2013: 2 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2016: 4 descendants cleared2025: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedP820021 · Softcon (Vifilcon a) Soft Contact Ext Wear Lens · Alcon Laboratories, Inc. · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 8 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant P820021 · Softcon (Vifilcon a) Soft Contact Ext Wear Lens · Alcon Laboratories, Inc. · 19830+5
  1. Root · 1 generation backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
  2. This deviceK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996
  3. Descendant · cites it directly · 22 of its ownK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
  4. Descendant · cites it directly · 21 of its ownK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
  5. Descendant · cites it directly · 12 of its ownK033701 Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives…Ciba Vision Corporation · 2003
  6. Descendant · cites it directly · 11 of its ownK050065 Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005 · Recalled
  7. Descendant · 2 generations on · 10 of its ownK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

1999: 12003: 12005: 22008: 12009: 12013: 22016: 42018: 42019: 22020: 32021: 12022: 12024: 12025: 12026: 1
1999high 4 (2016) · low 0 (2000)2026

Most influential descendants

Showing 5 of 26 · See all
  • K992446Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999 · cites it directly22descendants
  • K050213Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005 · cites it directly21descendants
  • K033701Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact…Ciba Vision Corporation · 2003 · cites it directly12descendants
  • K050065Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005 · cites it directly11descendants
  • K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009 · 2 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P820021Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc.1983—
0 (this device)K963487Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation1996—
+1K992446Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg.1999—
+1K050213Freshlook One-Day Color Contact LensCiba Vision Corporation2005—
+1K033701Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft…Ciba Vision Corporation2003—
+1K050065Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation20051
+2K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
200520
200810
200910
201320
201640
201840
201920
202030
202110
202210
202410
202510
202610
FIG. 1 — Lineage of K963487, 1983–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*P820021Softcon (Vifilcon a) Soft Contact Ext Wear Lens
Summary page 1
…and material type (Group Il / PVA) and include: . NewVues® (vifilcon A), FDA Group IV, disposable contact lenses for daily or extended wear, CIBA® Vision Corporation - P820021 . Excelens® (atlafiicon A), FDA Group I, soft contact lenses for daily or extended wear, CIBA® Vision Corporation - P890029 79…
Alcon Laboratories, Inc.1983—
*P890029Excelens (Atlafilcon a) Contact Lens
Summary page 1
…or extended wear, CIBA® Vision Corporation - P820021 . Excelens® (atlafiicon A), FDA Group I, soft contact lenses for daily or extended wear, CIBA® Vision Corporation - P890029 79 1003 11/25/96 16:37 FAX 404 418 4333 CIBAVISION-WCAPS @ CIB A CIBA Vision® Corporation 11460 Johns Creek Pa…
Ciba Vision Corporation1989—

Also cleared against P820021: 1 other device →

What descends from it? (26)

See all 26

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992446Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg.199922
K050213Freshlook One-Day Color Contact LensCiba Vision Corporation200521
K033701Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact…Ciba Vision Corporation200312
K050065Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation200511
K072777Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation20086
K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus…Alcon Laboratories, Inc.20182

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 6, 2003Not classifiedZ-0827-03OtherLenses may be labeled with the incorrect axis.

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, K992446 (Ciba Vision Johns Creek Mfg., 1999) has gone furthest, with 22 descendants of its own.
  • 1 other device also cites its predicate P820021.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

What is it indicated for?

DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in non-aphakic persons with non-diseased eyes.

DAILIES™ (neifilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use Daily Disposable Wear. DAILIES™ 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.

Also cleared against P820021

1 other device cites the same predicate.

  • K181558Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact…Gelflex Laboratories · 2018

More from Ciba Vision Corporation

210 FDA decisions under this applicant name. See the company

  • K133176Air Optix Colors, Air Optix Colors Toric, Air Optix Colors MultifocalCiba Vision Corporation · 2014
  • K123994Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus MultifocalCiba Vision Corporation · 2013
  • K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal ToricCiba Vision Corporation · 2012
  • K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
  • K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K963487 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963487: Dailies (Nelfilcon a) One-Day Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963487

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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