510(k) · Cleared
ClearedDAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 30, 2016 as substantially equivalent to K153642 (Alcon Laboratories, Inc., 2016) and 1 other predicate after a 195-day review. Its family tree reaches back 7 generations to 1983.
- Decided
- Nov 30, 2016
- Review
- 195 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to P820021 (1983). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
- 6 generations backK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
- 5 generations backK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
- 4 generations backK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
- 3 generations backK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
- 2 generations backK123994 Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies…Ciba Vision Corporation · 2013
- 1 generation backK153642 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES…Alcon Laboratories, Inc. · 2016
- This deviceK161391 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP…Alcon Laboratories, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | P820021 | Softcon (Vifilcon a) Soft Contact Ext Wear Lens | Alcon Laboratories, Inc. | 1983 | — |
| −6 | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens | Ciba Vision Corporation | 1996 | 1 |
| −5 | K992446 | Dailies (Nelfilcon a) One-Day | Ciba Vision Johns Creek Mfg. | 1999 | — |
| −4 | K050213 | Freshlook One-Day Color Contact Lens | Ciba Vision Corporation | 2005 | — |
| −3 | K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | Ciba Vision Corporation | 2009 | — |
| −2 | K123994 | Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort… | Ciba Vision Corporation | 2013 | — |
| −1 | K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort… | Alcon Laboratories, Inc. | 2016 | — |
| 0 (this device) | K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal… | Alcon Laboratories, Inc. | 2016 | — |
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 |
| 2008 | 1 | 0 |
| 2016 | 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 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 |
|---|---|---|---|
| * | K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus…Summary page 5…us® DAILIES® family (nelfilcon A) soft contact lenses, which are legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K153642 and K153643, respectively, both cleared January 20, 2016. IV. Device Description Focus® DAILIES® family and DAILIES® Aqu… | 2016 |
| * | K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesSummary page 5…family (nelfilcon A) soft contact lenses, which are legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K153642 and K153643, respectively, both cleared January 20, 2016. IV. Device Description Focus® DAILIES® family and DAILIES® AquaComfort Plu… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 16 ancestors have a recall of any class.
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. 2016, 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?
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 (275 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.
DATLIES® 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.
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 nondiscased 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.
All 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161391 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161391: DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161391
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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