510(k) · Cleared
ClearedSauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sauflon Pharmaceuticals, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Aug 5, 2013 as substantially equivalent to K032340 (Johnson & Johnson Vision Care, Inc., 2003) and 2 other predicates after a 175-day review. Its family tree reaches back 5 generations to 1981. 2 later devices descend from it.
- Decided
- Aug 5, 2013
- Review
- 175 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to P810005 (1981). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 4 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 3 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 2 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 1 generation backK073459 Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008
- This deviceK130342 Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with…Sauflon Pharmaceuticals, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK251573 VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic)…Vizionfocus, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK133740 Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon…Sauflon Pharmaceuticals, Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See all- K251573VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact LensVizionfocus, Inc. · 2025 · cites it directly0descendants
- K133740Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti Multifocal…Sauflon Pharmaceuticals, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −4 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −3 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −2 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −1 | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact Lenses | Ciba Vision Corporation | 2008 | — |
| 0 (this device) | K130342 | Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker | Sauflon Pharmaceuticals, Ltd. | 2013 | — |
| +1 | K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. | 2025 | — |
| +1 | K133740 | Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti… | Sauflon Pharmaceuticals, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K032340 | Vistakon (Galyfilcon a) Soft Contact LensSummary page 1…tantially equivalent to the Acuvue Advance (Galyfilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear single use which has been approved pursuant to K032340, and Air Optix (Lotrafilcon B3) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear which has been approved pursuant… | 2003 |
| * | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsSummary page 1…as been approved pursuant to K032340, and Air Optix (Lotrafilcon B3) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear which has been approved pursuant to K03391 9/K073459. 3.- DESCRIPTION of the DEVICE: The Sauflon Clariti (somofilcon A) Soft (Silicone Hydrogel) Contact Lens with UV Blocke… | 2004 |
| * | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact LensesSummary page 1…pproved pursuant to K032340, and Air Optix (Lotrafilcon B3) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear which has been approved pursuant to K03391 9/K073459. 3.- DESCRIPTION of the DEVICE: The Sauflon Clariti (somofilcon A) Soft (Silicone Hydrogel) Contact Lens with UV Blocker is ava… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K251573 (Vizionfocus, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032340.
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. 2013, 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 (LARITI tsomohilcoi A) Soft (hydrophilic) Contact Lens with UJV blocker is indicated for nontlil) disposable wvear for the correction ol refractive ametropia (myopia andhpropia) in phakiu or aphakic persons with non-diseased eyes that may exhibit astigmatism up to02.00 Diopters that does not interti~re with visual acuity. thie SAUrFLN CIARITI TORIC (somonflcoit A) Soft (hydrrophilic) Contact Lents with t I blocker is indicated for monthly…
Read the full statement (262 words)
The SAUFLON (LARITI tsomohilcoi A) Soft (hydrophilic) Contact Lens with UJV blocker is indicated for nontlil) disposable wvear for the correction ol refractive ametropia (myopia andhpropia) in phakiu or aphakic persons with non-diseased eyes that may exhibit astigmatism up to02.00 Diopters that does not interti~re with visual acuity.
thie SAUrFLN CIARITI TORIC (somonflcoit A) Soft (hydrrophilic) Contact Lents with t I blocker is indicated for monthly disposable wear tinr the optical correction of refmnctivec mopandhperopla) ini phallic tor aphakic persons with non-diseased eyes that way exhibit astigmatism up to 10.00 Diopters.
The SAUFLON CLARITI MUILTIFOCAL isontofilcon A) Sill (h~drophilic) Contact Lens with I'V blocker is indicated lbr monthly. disposable vwear lIm the optical correction or refraie ametropia (myopia and hy-pemopia) and/ort presbyopia in phnkie or aphakic persons with nion-dieased eyes that may require a reading addition of +3.00 Diopters or less and tna exhibit astigmiatism up to 1.50 Diopters or less.
The SAUFLU)N CLARITI MULTIFOCAL TORIC (somotilcon A) Soil thydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive anietropia (myopia and hyperopiaj and/or preshyopia in phakie or aphakic pertsons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters tnd tiat may%require a reading addition of +3.00 Dioptiers or less.
I he lense, ma> he prescribed for daily wear s'ithi removal (or cleanting und disinfectiotn (chemical. not heat) prior to reinsenion as recommended b%lte eye care professional.
Sauflon Clariti (sornotilcon A) Soil (hydrophilic) Contact tens with UV blocker help protect against Irdnsmission of harmful 0IV radiation itoIhe ct'Tnca atd into the eye.
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/K130342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130342: Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130342
Report an extraction error
Are you the manufacturer?
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