510(k) · Cleared
ClearedAurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vizionfocus, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 10, 2025 as substantially equivalent to K182247 (Vizionfocus, Inc., 2018) and 2 other predicates after a 108-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Apr 10, 2025
- Review
- 108 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K951893 (1995). 22 ancestors in all, the oldest P890023 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK951893 Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle…Permeable Technologies, Inc. · 1995
- 5 generations backK971164 Frequency 55 (Methafilcon a) Hydrophilic Contact LensAspect Vision Care, Ltd. · 1997
- 4 generations backK973063 Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. · 1997 · Recalled
- 3 generations backK982997 Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily…Aspect Vision Care, Ltd. · 1999
- 2 generations backK020392 Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for…CooperVision, Inc. · 2002
- 1 generation backK182247 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses…Vizionfocus, Inc. · 2018
- This deviceK243953 Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens…Vizionfocus, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55… | Permeable Technologies, Inc. | 1995 | — |
| −5 | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens | Aspect Vision Care, Ltd. | 1997 | — |
| −4 | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear | Aspect Vision Care, Ltd. | 1997 | 1 |
| −3 | K982997 | Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear… | Aspect Vision Care, Ltd. | 1999 | — |
| −2 | K020392 | Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear | CooperVision, Inc. | 2002 | — |
| −1 | K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted… | Vizionfocus, Inc. | 2018 | — |
| 0 (this device) | 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 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Summary page 7…Color) are substantially equivalent to the following predicate device(s): “ILICON (ocufilcon D)” By VIZIONFOCUS INC. 510(k) number; K182247 IV. DEVICE DESCRIPTION The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are hemisp… | 2018 |
| * | K020392 | Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily WearSummary page 9…DEVICE The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are substantially equivalent to the predicate devices identified (K020392 and K150293) in terms of the following: USAN contact lens material (ocufilcon D) FDA Group 4 (>50% H2O, ioni… | 2002 |
| * | K150293 | EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear…Summary page 9…VICE The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are substantially equivalent to the predicate devices identified (K020392 and K150293) in terms of the following: USAN contact lens material (ocufilcon D) FDA Group 4 (>50% H2O, ionic polymer)… | 2015 |
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 30 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K182247.
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. 2025, 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 SPHERICAL/ ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The TORIC Aurora (ocufilcon D) Soft…
Read the full statement (286 words)
The SPHERICAL/ ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The TORIC Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The MULTl FOCAL Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243953: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243953
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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