510(k) Report

510(k) · Cleared

Cleared

Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus Multifocal

K123994510(k) TraditionalCleared Feb 21, 201357-day reviewClass II21 CFR 886.5925

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 Feb 21, 2013 as substantially equivalent to K072777 (Ciba Vision Corporation, 2008) and 1 other predicate after a 57-day review. Its family tree reaches back 5 generations to 1983. 2 later devices descend from it.

Decided
Feb 21, 2013
Review
57 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to P820021 (1983). 13 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor2001: 2 other ancestors1999: 1 other ancestor1989: 1 other ancestor1984: 1 other ancestor2016: 2 descendants clearedP820021 · Softcon (Vifilcon a) Soft Contact Ext Wear Lens · Alcon Laboratories, Inc. · 1983K963487 · Dailies (Nelfilcon a) One-Day Soft Contact Lens · Ciba Vision Corporation · 1996 · recalledK992446 · Dailies (Nelfilcon a) One-Day · Ciba Vision Johns Creek Mfg. · 1999K050213 · Freshlook One-Day Color Contact Lens · Ciba Vision Corporation · 2005K083216 · Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses · Ciba Vision Corporation · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 6 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K083216 · Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses · Ciba Vision Corporation · 2009K050213 · Freshlook One-Day Color Contact Lens · Ciba Vision Corporation · 2005K992446 · Dailies (Nelfilcon a) One-Day · Ciba Vision Johns Creek Mfg. · 1999K963487 · Dailies (Nelfilcon a) One-Day Soft Contact Lens · Ciba Vision Corporation · 1996 · recalledP820021 · Softcon (Vifilcon a) Soft Contact Ext Wear Lens · Alcon Laboratories, Inc. · 1983−50
  1. Root · 5 generations backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
  2. 4 generations backK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
  3. 3 generations backK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
  4. 2 generations backK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
  5. 1 generation backK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
  6. This deviceK123994 Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies…Ciba Vision Corporation · 2013
  7. Descendant · cites it directly · 1 of its ownK153642 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES…Alcon Laboratories, Inc. · 2016
  8. Descendant · 2 generations on · 0 of its ownK161391 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP…Alcon Laboratories, Inc. · 2016

Most influential descendants

Showing 2 of 2 · See all
  • K153642DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus…Alcon Laboratories, Inc. · 2016 · cites it directly1descendant
  • K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus…Alcon Laboratories, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5P820021Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc.1983—
−4K963487Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation19961
−3K992446Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg.1999—
−2K050213Freshlook One-Day Color Contact LensCiba Vision Corporation2005—
−1K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation2009—
0 (this device)K123994Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort…Ciba Vision Corporation2013—
+1K153642DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort…Alcon Laboratories, Inc.2016—
+2K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal…Alcon Laboratories, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198910
199910
200120
200310
200510
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
FIG. 1 — Lineage of K123994, 1983–2016Source: 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
*K072777Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses
Summary page 1
…Lens Device Classification: Class 11[21 CFR 886.5925 (b) (1)] 3. Predicate Device: DAILIES® AquaComfort Plus® (nelfilcon A) contact lenses (cleared under K072777) and FOCUS® DAILIES® (nelfilcon A) lenses with print marks (cleared under K083216) have been identified as predicate device…
Ciba Vision Corporation2008—
*K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses
Summary page 1
…te Device: DAILIES® AquaComfort Plus® (nelfilcon A) contact lenses (cleared under K072777) and FOCUS® DAILIES® (nelfilcon A) lenses with print marks (cleared under K083216) have been identified as predicate devices for this Premarket Notification. 4. Description of Device: The lens material is…
Ciba Vision Corporation2009—

Also cleared against K072777: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K153642DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus…Alcon Laboratories, Inc.20161

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 30 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
  • 3 of the 13 ancestors have a recall of any class.
  • Of its descendants, K153642 (Alcon Laboratories, Inc., 2016) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K072777.

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. 2013, this device’s year, is highlighted.

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® AquaComfort Plus® (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 (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive…

Read the full statement (179 words)

DAILIES® AquaComfort Plus® (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 (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 6.00 diopters (D) or less of astigmatism.

DAILIES® AquaComfort Plus® Multifocal (nelfilcon 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 +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.

DAILIES® (nelfilcon 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.

Also cleared against K072777

1 other device cites the same predicate.

  • K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES…Alcon Laboratories, Inc. · 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
  • 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
  • K072777Ciba Vision (Nelfilcon a) One-Day 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/K123994 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123994: Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus Multifocal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123994

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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