510(k) · Cleared
ClearedDailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal Toric
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 Mar 30, 2012 as substantially equivalent to K100349 (Johnson & Johnson Vision Care, Inc., 2010) after a 155-day review. Its family tree reaches back 3 generations to 1996. 12 later devices descend from it.
- Decided
- Mar 30, 2012
- Review
- 155 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962804 (1996). 4 ancestors in all. 12 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 2 generations backK073485 Vistakon (Narafilcon) a Soft Contact LensJohnson & Johnson Vision Care, Inc. · 2008
- 1 generation backK100349 Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc. · 2010
- This deviceK113168 Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal…Ciba Vision Corporation · 2012
- Descendant · cites it directly · 4 of its ownK182902 Precision1Alcon Laboratories, Inc. · 2018 · Recalled
- Descendant · cites it directly · 4 of its ownK180398 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK230785 Precision1, Precision1 for AstigmatismAlcon Laboratories, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK233856 Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for…Alcon Laboratories, Inc. · 2023 · Recalled
- Descendant · cites it directly · 2 of its ownK232921 DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal…Alcon Laboratories, Inc. · 2023 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K182902Precision1Alcon Laboratories, Inc. · 2018 · cites it directly4descendants
- K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc. · 2018 · cites it directly4descendants
- K230785Precision1, Precision1 for AstigmatismAlcon Laboratories, Inc. · 2023 · 2 generations on3descendants
- K233856Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…Alcon Laboratories, Inc. · 2023 · 2 generations on2descendants
- K232921DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…Alcon Laboratories, Inc. · 2023 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −2 | K073485 | Vistakon (Narafilcon) a Soft Contact Lens | Johnson & Johnson Vision Care, Inc. | 2008 | — |
| −1 | K100349 | Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV Blocker | Johnson & Johnson Vision Care, Inc. | 2010 | — |
| 0 (this device) | K113168 | Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies… | Ciba Vision Corporation | 2012 | — |
| +1 | K182902 | Precision1 | Alcon Laboratories, Inc. | 2018 | 1 |
| +1 | K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES… | Alcon Laboratories, Inc. | 2018 | — |
| +2 | K230785 | Precision1, Precision1 for Astigmatism | Alcon Laboratories, Inc. | 2023 | — |
| +2 | K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism… | Alcon Laboratories, Inc. | 2023 | 1 |
| +1 | K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES… | Alcon Laboratories, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K100349 | Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerSummary page 1…fered saline. Narafilcon B lenses belong to ISO Group V (silicone hydrogel). Johnson & Johnson VISTAKON 1-DAY ACUVUE TruEye lenses have FDA 51 0(k) clearance per K1 00349, 21 -May-201 0. 4. Description of Device: The lens material is 33% water and 67% delefilcon A, a silicone containing hydrogel… | 2010 |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182902 | Precision1 | 2018 | 4 |
| K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort… | 2018 | 4 |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®… | 2023 | 2 |
| K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort… | 2018 | 2 |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | 2026 | 0 |
| K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1… | 2019 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K182902 (Alcon Laboratories, Inc., 2018) has gone furthest, with 4 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. 2012, 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 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) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes…
Read the full statement (216 words)
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) toric 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 6.00 diopters (D) or less 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.
DAILIES TOTAL1® (delefilcon A) multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 6.00 diopters (D) or less of astigmatism and who may require a reading addition of +3.00 diopters (D) or less.
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/K113168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113168: Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal Toric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113168
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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