510(k) · Cleared
ClearedVisco Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visco Vision, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jun 22, 2015 as substantially equivalent to K052560 (CooperVision, Inc., 2005) after a 396-day review. Its family tree reaches back 5 generations to 1981. 12 later devices descend from it.
- Decided
- Jun 22, 2015
- Review
- 396 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to P810005 (1981). 7 ancestors in all. 12 later devices descend from it, 3 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 backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- This deviceK141348 Visco Soft Contact LensVisco Vision, Inc. · 2015
- Descendant · cites it directly · 8 of its ownK160344 Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens…Visco Vision, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK171447 OxyPure Color Silicone Hydrogel Soft Contact LensesVisco Vision, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK193399 Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK180322 Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK262495 Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B)…Visco Vision, Inc. · 2016 · cites it directly8descendants
- K171447OxyPure Color Silicone Hydrogel Soft Contact LensesVisco Vision, Inc. · 2017 · cites it directly2descendants
- K193399Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2020 · 2 generations on1descendant
- K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc. · 2018 · 2 generations on1descendant
- K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026 · 3 generations on0descendants
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 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| 0 (this device) | K141348 | Visco Soft Contact Lens | Visco Vision, Inc. | 2015 | — |
| +1 | K160344 | Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy… | Visco Vision, Inc. | 2016 | — |
| +1 | K171447 | OxyPure Color Silicone Hydrogel Soft Contact Lenses | Visco Vision, Inc. | 2017 | — |
| +2 | K193399 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | 2020 | — |
| +2 | K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | Visco Vision, Inc. | 2018 | — |
| +3 | K262495 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2025 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K052560 | Biofinity (Comfilcon a) Soft Contact LensSummary page 5…: Predicate Device Name Biofinity (comfilcon A) Manufacturer CooperVision Inc. 510(k) Number K052560 Product Code LPL, MVN 5.7 Device Description - The VISCO Soft Contact Lens… | 2005 |
| † | K000384 | Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, Cooperflex | 2000 |
What descends from it? (12)
See all 123 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 34 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K160344 (Visco Vision, Inc., 2016) has gone furthest, with 8 descendants of its own.
- 14 other devices also cite its predicate K052560.
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. 2015, 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 VISCO Soft (Hydrophilic) Contact Lenses is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection…
Read the full statement (104 words)
The VISCO Soft (Hydrophilic) Contact Lenses is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The VISCO Soft (Hydrophilic) Contact Lenses 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/K141348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141348: Visco Soft 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/K141348
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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