510(k) · Cleared
Recalled · Class II · 2013Biomedics (Ocufilcon D) Soft (Hydrophilic) 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 Jan 5, 2010 as substantially equivalent to K012425 (Ocular Sciences Puerto Rico, Inc., 2001) and 2 other predicates after a 244-day review. Its family tree reaches back 4 generations to 1994. 9 later devices descend from it. It has been recalled once.
- Decided
- Jan 5, 2010
- Review
- 244 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K942214 (1994). 9 ancestors in all, the oldest P890023 (1989). 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK942214 H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994
- 3 generations backK972303 Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997
- 2 generations backK984046 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999
- 1 generation backK012425 Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc. · 2001
- This deviceK091339 Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK181232 Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact…Largan Medical Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK182523 Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic)…Largan Medical Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK182247 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses…Vizionfocus, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK141280 Ilens (Ocufilcon D) Daily Soft Contact LensSeinoh Optical Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK243953 Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens…Vizionfocus, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K181232Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV…Largan Medical Co., Ltd. · 2018 · cites it directly3descendants
- K182523Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd. · 2018 · 2 generations on2descendants
- K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Vizionfocus, Inc. · 2018 · cites it directly2descendants
- K141280Ilens (Ocufilcon D) Daily Soft Contact LensSeinoh Optical Co., Ltd. · 2014 · cites it directly1descendant
- K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)Vizionfocus, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942214 | H55 Hydrophilic Contact Lens | Martin S. Knopf Assoc., Inc. | 1994 | — |
| −3 | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens | Ocular Sciences Puerto Rico, Inc. | 1997 | — |
| −2 | K984046 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens | Ocular Sciences Puerto Rico, Inc. | 1999 | — |
| −1 | K012425 | Biomedics UV Multifocal | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| 0 (this device) | K091339 | Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2010 | — |
| +1 | K181232 | Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan… | Largan Medical Co., Ltd. | 2018 | — |
| +2 | K182523 | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | 2018 | — |
| +1 | K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted… | Vizionfocus, Inc. | 2018 | — |
| +1 | K141280 | Ilens (Ocufilcon D) Daily Soft Contact Lens | Seinoh Optical Co., Ltd. | 2014 | — |
| +2 | K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus, Inc. | 2025 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K973003 | ocufilcon D Daily Wear Soft Contact Lenses Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K012425 | Biomedics UV MultifocalSummary page 4…The predicate devices are the ocufilcon D Daily Wear Soft Contact Lenses: Predicate K97303, August 20, 1997; Devices K012425, October 12, 2001; Information K020193, February 28, 2002; ahd P8900231S004, Au… | 2001 |
| * | K020193 | Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact LensSummary page 4…ar Soft Contact Lenses: Predicate K97303, August 20, 1997; Devices K012425, October 12, 2001; Information K020193, February 28, 2002; ahd P8900231S004, August 28, 1996; 9. Nonclinical Tests Performed:… | 2002 |
| * | P890023 | H55 Hydrophilic Contact LensSummary page 4…August 20, 1997; Devices K012425, October 12, 2001; Information K020193, February 28, 2002; ahd P8900231S004, August 28, 1996; 9. Nonclinical Tests Performed: Physiochemnical and toxicological studies were conducte… | 1989 |
What descends from it? (9)
3 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 |
|---|---|---|---|---|
| Nov 20, 2013 | Class II | Z-0543-2014 | Incorrect or no expiration date | Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K181232 (Largan Medical Co., Ltd., 2018) has gone furthest, with 3 descendants of its own.
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. 2010, 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?
Spherical and Aspherical - Biomedics 55 (ocufilcon D.) SPHERE and ASPHERE 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 - 20.000 to +20.000 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. Toric - Biomedics 55 (ocufilcon D) TORIC Soft Contact lenses are…
Read the full statement (234 words)
Spherical and Aspherical - Biomedics 55 (ocufilcon D.) SPHERE and ASPHERE 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 - 20.000 to +20.000 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
Toric - Biomedics 55 (ocufilcon D) 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 -5.00 diopters.
Multifocal - Biomedics 55 (ocufilcon D) MULTIFOCAL 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 +19.00 diopters and with add powers from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.
The Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for single use daily disposable wear or for planned replacement. As prescribed for single use daily disposable wear, patients are instructed to dispose of the lens at each removal. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091339 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091339: Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091339
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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