510(k) · Cleared
ClearedIlens (Ocufilcon D) Daily Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seinoh Optical Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jul 18, 2014 as substantially equivalent to K091339 (CooperVision, Inc., 2010) after a 63-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Jul 18, 2014
- Review
- 63 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K942214 (1994). 10 ancestors in all, the oldest P890023 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK942214 H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994
- 4 generations backK972303 Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997
- 3 generations backK984046 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999
- 2 generations backK012425 Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc. · 2001
- 1 generation backK091339 Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010 · Recalled
- This deviceK141280 Ilens (Ocufilcon D) Daily Soft Contact LensSeinoh Optical Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK152657 SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K942214 | H55 Hydrophilic Contact Lens | Martin S. Knopf Assoc., Inc. | 1994 | — |
| −4 | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens | Ocular Sciences Puerto Rico, Inc. | 1997 | — |
| −3 | K984046 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens | Ocular Sciences Puerto Rico, Inc. | 1999 | — |
| −2 | K012425 | Biomedics UV Multifocal | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| −1 | K091339 | Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2010 | 1 |
| 0 (this device) | K141280 | Ilens (Ocufilcon D) Daily Soft Contact Lens | Seinoh Optical Co., Ltd. | 2014 | — |
| +1 | K152657 | SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens | Smart Performer Corp., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K091339 | Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensSummary page 2…d Equivalent Device: Predicate Device Name Biomedics® 55 (ocufilcon D) Manufacturer CooperVision, Inc. 5 10O(k) Number K091339 Product Code LPL, MVN 7 Device Description - The iLenst (ocufilcon D) Daily Wear Soft (Hydrophi… | 2010 |
| † | K013649 | Sauflon 55 UV Soft (Hydrophilic) Contact Lens | 2001 |
| † | K000384 | Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, Cooperflex | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152657 | SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens | 2016 | 0 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K152657 (Smart Performer Corp., Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K091339.
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. 2014, 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 iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refmactive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.001D to +20.001D. The lens may be worn by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. Eye care practitioners may prescribe the lens…
Read the full statement (141 words)
The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refmactive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.001D to +20.001D. The lens may be worn by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. Eye care practitioners may prescribe the lens for either single-use disposable wear or for frequent replacement wear. When prescribed for frequent replacement wear, the lens may be disinfected using a chemical or hydrogen peroxide disinfcting system. As prescribed for single use daily disposable wear, patients are instrucd to dispose of the lens at each removal. The iLens® Daily Wear 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/K141280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141280: Ilens (Ocufilcon D) Daily 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/K141280
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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