510(k) · Cleared
ClearedSauflon Clariti 1 Day with Tint (Toric/Multifocal)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Souflon Pharmaceuticals, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Mar 4, 2014 as substantially equivalent to K130331 (Sauflon Pharmaceuticals, Ltd., 2013) and 3 other predicates after a 112-day review. Its family tree reaches back 6 generations to 1981.
- Decided
- Mar 4, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to P810005 (1981). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 5 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 4 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 3 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 2 generations backK073459 Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008
- 1 generation backK130331 Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily…Sauflon Pharmaceuticals, Ltd. · 2013 · Recalled
- This deviceK133472 Sauflon Clariti 1 Day with Tint (Toric/Multifocal)Souflon Pharmaceuticals, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −5 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −4 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −3 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −2 | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact Lenses | Ciba Vision Corporation | 2008 | — |
| −1 | K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable… | Sauflon Pharmaceuticals, Ltd. | 2013 | 17 |
| 0 (this device) | K133472 | Sauflon Clariti 1 Day with Tint (Toric/Multifocal) | Souflon Pharmaceuticals, Ltd. | 2014 | — |
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 |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…Summary page 1…ing Tint to be substntially equivalent tLo the Sauflom Clariti I Day (somoikcon A) Soft (hydrophilic) Daily Disposable Contact Lens with USV Blocker, cleared pursuant to K 130331. Acuvue Trueye.(Nara filIcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear single use which has keen approv… | 2013 |
| * | K073485 | Vistakon (Narafilcon) a Soft Contact LensSummary page 1…ared pursuant to K 130331. Acuvue Trueye.(Nara filIcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear single use which has keen approved pursuant to K073485, and Air Optix (Lotrafilcon 13) Soft (Hlydrophilic) Visibility Tinted Contactizens for Daoily Wear which has been approved pursua… | 2008 |
| * | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsSummary page 1…keen approved pursuant to K073485, and Air Optix (Lotrafilcon 13) Soft (Hlydrophilic) Visibility Tinted Contactizens for Daoily Wear which has been approved pursuant to K033919/K073459. SAUFLON CLARITI I DAY TINTED CONTACT LENS 510(k) 3.- DESCRIPTION of Ihe.DEVICE: The Sauflon Clariti I… | 2004 |
| * | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact LensesSummary page 1…proved pursuant to K073485, and Air Optix (Lotrafilcon 13) Soft (Hlydrophilic) Visibility Tinted Contactizens for Daoily Wear which has been approved pursuant to K033919/K073459. SAUFLON CLARITI I DAY TINTED CONTACT LENS 510(k) 3.- DESCRIPTION of Ihe.DEVICE: The Sauflon Clariti I Day (so… | 2008 |
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 4 companies; a new generation was cleared every 4.9 years on median.
- 5 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K130331.
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. 2014, 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?
The SAUFLON CLARITI I DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blacker and Handling Tint is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hypcropia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmiatisnm up to 2.00 Diopters that does not interfere with visual acuity. The SAUFLO)N CLARITI I DAY TORIC (sontofilcon A) Soft (hydrophilic) Daily…
Read the full statement (279 words)
The SAUFLON CLARITI I DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blacker and Handling Tint is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hypcropia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmiatisnm up to 2.00 Diopters that does not interfere with visual acuity.
The SAUFLO)N CLARITI I DAY TORIC (sontofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.
The SAUFLON CLARITI I DAY MIULTIFOCAL (somrnoikon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ninetropia (myopia and hyperopia) Mnd/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.
The SAUFLON CLARITI I DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +-4.00 Diopters or less.
Sauflon Clariti I Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact lens with UV blocker and Handling Tint help protect against transmission of harmful UV radiation to the cornea and into the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133472: Sauflon Clariti 1 Day with Tint (Toric/Multifocal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133472
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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