510(k) · Cleared
ClearedPrecision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric
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 Jan 13, 2025 as substantially equivalent to K233856 (Alcon Laboratories, Inc., 2023) and 1 other predicate after a 25-day review. Its family tree reaches back 7 generations to 1981. 1 later device descends from it.
- Decided
- Jan 13, 2025
- Review
- 25 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to P810005 (1981). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 6 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 5 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 4 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 3 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 2 generations backK210436 Total30, Total30 for Astigmatism, Total30 Multifocal, Total30…Alcon Laboratories, Inc. · 2021
- 1 generation backK233856 Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for…Alcon Laboratories, Inc. · 2023 · Recalled
- This deviceK243909 Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies…Alcon Laboratories, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK254052 DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalAlcon Laboratories, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K254052DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalAlcon Laboratories, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −6 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −5 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −4 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −3 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −2 | K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal… | Alcon Laboratories, Inc. | 2021 | — |
| −1 | K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism… | Alcon Laboratories, Inc. | 2023 | 1 |
| 0 (this device) | K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for… | Alcon Laboratories, Inc. | 2025 | — |
| +1 | K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…Summary page 5…Lenses, Soft Contact, Dailh | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233856 (P1) and Kg| | Precision1 / Dailies Total1 LPL; MVN Device Description Summary 21 CFR 807.92(a)(4) Precision1 (P1) (verofilcon… | 2023 |
| * | K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…Summary page 6…d devices in the US under 510(k) 1<233856, and Dailies Total 1 (delefilcon A) family soft contact lenses, which are legally commercialized devices in the US under 510(k) K232921. Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) T… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | 2026 | 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 44 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 17 ancestors have a recall of any class.
- Of its descendants, K254052 (Alcon Laboratories, Inc., 2026) has gone furthest, with 0 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. 2025, 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?
Precision1 (verofilcon 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 and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Precision1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or…
Read the full statement (352 words)
Precision1 (verofilcon 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 and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Precision1 for Astigmatism (verofilcon 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 and 6.00 diopters (D) or less of astigmatism.
Precision1 lenses are to be prescribed for single use, daily disposable wear, as recommended by the eye care professional. 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 that does not interfere with visual acuity.
Dailies Total1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) 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 (D) of astigmatism that does not interfere with visual acuity.
Dailies Total1 for Astigmatism (delefilcon A) 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 6.00 diopters (D) of astigmatism.
Dailies Total1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) 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 6.00 diopters (D) of astigmatism.
Dailies Total1 lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. 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/K243909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243909: Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243909
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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