510(k) · Cleared
Recalled · Class II · 2025Sus (Stenfilcon a) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperVision, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Aug 30, 2013 as substantially equivalent to K071736 (CooperVision, Inc., 2008) and 1 other predicate after a 108-day review. Its family tree reaches back 6 generations to 1981. 10 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 30, 2013
- Review
- 108 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 6 generations to P810005 (1981). 10 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- 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 backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 1 generation backK071736 Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2008 · Recalled
- This deviceK131378 Sus (Stenfilcon a) Contact LensCooperVision, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK160803 Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensCooperVision, Inc. · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK191763 MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay…CooperVision, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK223397 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens…Hoya Lamphun, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK213164 Avaira VitalityCooperVision, Inc. · 2021 · Recalled
- Descendant · cites it directly · 1 of its ownK193399 Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensCooperVision, Inc. · 2016 · cites it directly3descendants
- K191763MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…CooperVision, Inc. · 2020 · cites it directly2descendants
- K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd. · 2024 · 2 generations on1descendant
- K213164Avaira VitalityCooperVision, Inc. · 2021 · 2 generations on1descendant
- K193399Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2020 · cites it directly1descendant
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 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −1 | K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2008 | 2 |
| 0 (this device) | K131378 | Sus (Stenfilcon a) Contact Lens | CooperVision, Inc. | 2013 | — |
| +1 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | CooperVision, Inc. | 2016 | 1 |
| +1 | K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)… | CooperVision, Inc. | 2020 | — |
| +2 | K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina… | Hoya Lamphun, Ltd. | 2024 | — |
| +2 | K213164 | Avaira Vitality | CooperVision, Inc. | 2021 | 1 |
| +1 | K193399 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensSummary page 1…Product Code: LPL. MVN Predicate Device(s) Material CooperVision AVAIRA (entilcon A) K07 1736 (Silicone Hydrogel) Indication, Wear Schedule CooperV… | 2008 |
| * | K020389 | Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact LensSummary page 1…(Silicone Hydrogel) Indication, Wear Schedule CooperVision CLEARSIGHT I DAY (ocufilcon B) K020389 (Daily wear, single use) 510(k) Summary, continued Description of Device " The SUJS (stenfilcon A) Contact L… | 2002 |
What descends from it? (10)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2025 | Class II | Z-2608-2025 | Under Investigation by firm | One lot manufactured with an invalid sterilization cycle. |
| Aug 22, 2025 | Class II | Z-2606-2025 | Under Investigation by firm | One lot manufactured with an invalid sterilization cycle. |
| Aug 22, 2025 | Class II | Z-2607-2025 | Under Investigation by firm | One lot manufactured with an invalid sterilization cycle. |
| Feb 27, 2025 | Class II | Z-1455-2025 | Process control | a limited number of lots were manufactured with an incorrect cylinder power. |
| Dec 27, 2022 | Class II | Z-1014-2023 | Process control | Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity. |
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.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K160803 (CooperVision, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K071736.
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?
Aspherical SUS (stenfilcan A)ASPHERE Soft Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia in aphakic and non-aphakic persons with non-diseased eye in powers from -20.00 D to +20.00 D. The lenses may be worn by persons who exhibit astigmatism of -2.00 D or less that does not Interfere with visual acuity. Toric SUS (stenfilcon A) TORIC Soft Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia…
Read the full statement (190 words)
Aspherical
SUS (stenfilcan A)ASPHERE Soft Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia in aphakic and non-aphakic persons with non-diseased eye in powers from -20.00 D to +20.00 D. The lenses may be worn by persons who exhibit astigmatism of -2.00 D or less that does not Interfere with visual acuity.
Toric
SUS (stenfilcon A) TORIC Soft Contact Lenses are indicated 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 -10.00 diopters.
Multifocal
SUS (stenflcon A) MULTIFOCAL Soft Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 0 or less that does not interfere with visual acuity.
Multifocal toric
SUS (stenflcon A) MULTIFOCAL TORIC Soft Contact Lenses are indicated for the optical correction of distance and near vision in presbyopia phakic or aphakic persons with non-diseased eyes who may have 10.00 D of stigmatism or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131378: Sus (Stenfilcon a) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131378
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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