510(k) · Cleared
ClearedInnova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innova Vision, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 17, 2024 as substantially equivalent to K232139 (Innova Vision, Inc., 2023) and 2 other predicates after a 54-day review. Its family tree reaches back 7 generations to 1981.
- Decided
- Apr 17, 2024
- Review
- 54 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to P810005 (1981). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 6 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 5 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 4 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 3 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 2 generations backK160212 ACUVUE (senofilcon C) Soft Contact LensJohnson & Johnson Vision Care, Inc. · 2016 · Recalled
- 1 generation backK232139 Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic)…Innova Vision, Inc. · 2023
- This deviceK240519 Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily…Innova Vision, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −6 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −5 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −4 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −3 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −2 | K160212 | ACUVUE (senofilcon C) Soft Contact Lens | Johnson & Johnson Vision Care, Inc. | 2016 | 1 |
| −1 | K232139 | Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Innova Vision, Inc. | 2023 | — |
| 0 (this device) | K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft… | Innova Vision, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K232139 | Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensSummary page 7…redicate devices: ƒ “Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens” By Innova Vision, Inc. 510(k) number; K232139 Primary Predicate ƒ “Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens” By Inno… | 2023 |
| * | K222954 | Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensSummary page 7…Primary Predicate ƒ “Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens” By Innova Vision, Inc. 510(k) number; K222954 Primary Predicate ƒ “Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30… | 2023 |
| * | K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30…Summary page 7…tal30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere” By Alcon Laboratories Inc. 510(k) number; K210436 Reference Predicate IV. DEVICE DESCRIPTION The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Da… | 2021 |
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 43 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 5 of the 19 ancestors have a recall of any class.
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. 2024, 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/Asphere: Innova Vision Sphere and Asphere (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated 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 2.00 diopters or less that does not interfere with visual acuity. Torie: Innova Vision Toric (inifilcon A) Silicone Hydrogel…
Read the full statement (358 words)
Sphere/Asphere:
Innova Vision Sphere and Asphere (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated 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 2.00 diopters or less that does not interfere with visual acuity.
Torie:
Innova Vision Toric (inifilcon A) Silicone Hydrogel 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 -2.25 diopters.
Multifocal:
Innova Vision Multifocal (inifilcon A) Silicone Hydrogel 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 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.
Multifocal Torie:
Innova Vision Multifocal Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.
Eye Care Practitioners may prescribe the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.
When prescribed for frequent/planned replacement, the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be discarded after each removal.
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/K240519 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240519: Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240519
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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