510(k) Report

510(k) · Cleared

Cleared

Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal

K180669510(k) TraditionalCleared Apr 27, 201844-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

Alcon Laboratories, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Apr 27, 2018 as substantially equivalent to K172066 (Alcon Laboratories, Inc., 2017) and 3 other predicates after a 44-day review. Its family tree reaches back 6 generations to 1983. 2 later devices descend from it.

Decided
Apr 27, 2018
Review
44 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to P820021 (1983). 19 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2012: 1 other ancestor2010: 1 other ancestor2001: 2 other ancestors1999: 1 other ancestor1984: 1 other ancestor2008: 1 other ancestor2005: 1 other ancestor1996: 1 other ancestor1989: 1 other ancestor2003: 2 other ancestors2020: 1 descendant cleared2019: 1 descendant 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 · 2009K153643 · Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives · Alcon Laboratories, Inc. · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 4 other ancestors4 generations back: 2 other ancestors 1 generation forward: 2 descendants K153643 · Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives · Alcon Laboratories, Inc. · 2016K083216 · 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 · 6 generations backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
  2. 5 generations backK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
  3. 4 generations backK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
  4. 3 generations backK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
  5. 2 generations backK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
  6. 1 generation backK153643 Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. · 2016
  7. This deviceK180669 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2018
  8. Descendant · cites it directly · 0 of its ownK202036 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2020
  9. Descendant · cites it directly · 0 of its ownK182782 DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for…Alcon Laboratories, Inc. · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc. · 2020 · cites it directly0descendants
  • K182782DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1…Alcon Laboratories, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6P820021Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc.1983—
−5K963487Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation19961
−4K992446Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg.1999—
−3K050213Freshlook One-Day Color Contact LensCiba Vision Corporation2005—
−2K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation2009—
−1K153643Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc.2016—
0 (this device)K180669Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES…Alcon Laboratories, Inc.2018—
+1K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES…Alcon Laboratories, Inc.2020—
+1K182782DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM…Alcon Laboratories, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198910
199610
199910
200120
200320
200510
200810
201010
201210
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202010
FIG. 1 — Lineage of K180669, 1983–2020Source: 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? (4)

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
*K172066DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort…
Summary page 8
…modifications of the same predicate devices, i.e. the currently legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K172066 (DAILIES AquaComfort Plus products), K153643 (Focus DAILIES products), K050213 (FreshLook One-Day product) and K113168 (DAILI…
Alcon Laboratories, Inc.2017—
*K153643Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
Summary page 8
…i.e. the currently legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K172066 (DAILIES AquaComfort Plus products), K153643 (Focus DAILIES products), K050213 (FreshLook One-Day product) and K113168 (DAILIES Total1 products). IV. Device Descript…
Alcon Laboratories, Inc.2016—
*K050213Freshlook One-Day Color Contact Lens
Summary page 8
…cialized devices in the US per the following most recent US FDA 510(k) clearances: K172066 (DAILIES AquaComfort Plus products), K153643 (Focus DAILIES products), K050213 (FreshLook One-Day product) and K113168 (DAILIES Total1 products). IV. Device Description Focus DAILIES, DAILIES AquaCom…
Ciba Vision Corporation2005—
*K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total…
Summary page 8
…wing most recent US FDA 510(k) clearances: K172066 (DAILIES AquaComfort Plus products), K153643 (Focus DAILIES products), K050213 (FreshLook One-Day product) and K113168 (DAILIES Total1 products). IV. Device Description Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES…
Ciba Vision Corporation2012—

Also cleared against K172066: 2 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc.20200
K182782DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1…Alcon Laboratories, Inc.20190

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 35 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
  • 4 of the 19 ancestors have a recall of any class.
  • Of its descendants, K202036 (Alcon Laboratories, Inc., 2020) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K172066.

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. 2018, 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?

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 (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…

Read the full statement (509 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 (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.

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.

All DAILIES AquaComfort Plus (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.

FreshLook spherical (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 (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.

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 TOTAL1 (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism.

DAILIES TOTAL1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism .

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K172066

2 other devices cite the same predicate.

  • K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES…Alcon Laboratories, Inc. · 2018
  • K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP…Alcon Laboratories, Inc. · 2018

More from Alcon Laboratories, Inc.

489 FDA decisions under this applicant name. See the company

  • P930014/S164AcrySof® Posterior Chamber Intraocular Lens and Delivery SystemsAlcon Laboratories, Inc. · 2026
  • P930014/S163Acrosof Posterior Chamber Intraocular LensAlcon Laboratories, Inc. · 2026
  • P930014/S165AcrySof® Posterior Chamber Intraocular Lens and Delivery SystemsAlcon Laboratories, Inc. · 2026
  • P010019/S087Focus Night and Day (Lotrafilcon a) Soft Contact LensesAlcon Laboratories, Inc. · 2026
  • P930014/S161AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL…Alcon Laboratories, Inc. · 2026

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/K180669 · printed Nov 6, 2026

Cite this page

510(k) Report. “K180669: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180669

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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