510(k) · Cleared
ClearedVizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vizionfocus, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Sep 10, 2025 as substantially equivalent to K130342 (Sauflon Pharmaceuticals, Ltd., 2013) and 1 other predicate after a 111-day review. Its family tree reaches back 8 generations to 1981.
- Decided
- Sep 10, 2025
- Review
- 111 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to P810005 (1981). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 7 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 6 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 5 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 4 generations backK073459 Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008
- 3 generations backK130331 Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily…Sauflon Pharmaceuticals, Ltd. · 2013 · Recalled
- 2 generations backK181920 Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable…CooperVision, Inc. · 2018 · Recalled
- 1 generation backK242413 VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic)…Vizionfocus, Inc. · 2024
- This deviceK251573 VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic)…Vizionfocus, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −7 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −6 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −5 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −4 | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact Lenses | Ciba Vision Corporation | 2008 | — |
| −3 | K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable… | Sauflon Pharmaceuticals, Ltd. | 2013 | 17 |
| −2 | K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens… | CooperVision, Inc. | 2018 | 1 |
| −1 | K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily… | Vizionfocus, Inc. | 2024 | — |
| 0 (this device) | K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. | 2025 | — |
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 |
| 2013 | 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 |
|---|---|---|---|
| * | K130342 | Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerSummary page 6…vices: “Sauflon Clariti (Somofilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker” By Sauflon Pharmaceuticals, Ltd. 510(k) number; K130342 Product Code: LPL Primary Predicate “VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophi… | 2013 |
| * | K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact…Summary page 6…cate “VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens” By Vizionfocus, Inc. 510(k) number; K242413 Product Code: MVN; LPL Reference Predicate IV. DEVICE DESCRIPTION The VizionFocus (somofilcon A) S… | 2024 |
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 44 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 6 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K130342.
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?
Sphere and Asphere: The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the spherical and aspheric design are indicated for monthly disposable wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual…
Read the full statement (256 words)
Sphere and Asphere:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the spherical and aspheric design are indicated for monthly disposable wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the toric design is indicated for monthly disposable wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
Multifocal:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the multifocal design is indicated for monthly disposable wear for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251573 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251573: VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251573
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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