510(k) · Cleared
ClearedEzvue (Ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-See Vision Technology, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jun 16, 2009 as substantially equivalent to K972303 (Ocular Sciences Puerto Rico, Inc., 1997) after a 260-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Jun 16, 2009
- Review
- 260 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942214 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK942214 H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994
- 1 generation backK972303 Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997
- This deviceK082879 Ezvue (Ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily WearI-See Vision Technology, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK150293 EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue…I-See Vision Technology, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK182247 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses…Vizionfocus, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK243953 Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens…Vizionfocus, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK192225 Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily…Vizionfocus, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K150293EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear…I-See Vision Technology, Inc. · 2015 · cites it directly3descendants
- K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Vizionfocus, Inc. · 2018 · 2 generations on2descendants
- K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)Vizionfocus, Inc. · 2025 · 2 generations on0descendants
- K192225Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact LensesVizionfocus, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942214 | H55 Hydrophilic Contact Lens | Martin S. Knopf Assoc., Inc. | 1994 | — |
| −1 | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens | Ocular Sciences Puerto Rico, Inc. | 1997 | — |
| 0 (this device) | K082879 | Ezvue (Ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily Wear | I-See Vision Technology, Inc. | 2009 | — |
| +1 | K150293 | EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft… | I-See Vision Technology, Inc. | 2015 | — |
| +2 | K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted… | Vizionfocus, Inc. | 2018 | — |
| +2 | K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus, Inc. | 2025 | — |
| +3 | K192225 | Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact… | Vizionfocus, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensSummary page 1…j Predicate Device: Hydron Biomedics 55 (Ocufilcon D) Visibility Tint Molded daily wear soft contact lens cleared via K972303 Ocular Sciences / American Hydron Inc. Indications for Use EZvue (Ocufilcon -D) Soft (hydrophilic) Contact Lens for Daily… | 1997 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150293 | EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear… | 2015 | 3 |
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 15 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K150293 (I-See Vision Technology, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K972303.
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. 2009, 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?
EZvue (Ocufilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes who may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity..
Eye care practitioners may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082879: Ezvue (Ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082879
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