510(k) · Cleared
ClearedLeo Colors, Leo Aspheric Colors, Leo Toric Colors
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 Jul 23, 2004 as substantially equivalent to K971164 (Aspect Vision Care, Ltd., 1997) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jul 23, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K951893 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK951893 Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle…Permeable Technologies, Inc. · 1995
- 2 generations backK971164 Frequency 55 (Methafilcon a) Hydrophilic Contact LensAspect Vision Care, Ltd. · 1997
- 1 generation backK973063 Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. · 1997 · Recalled
- This deviceK041138 Leo Colors, Leo Aspheric Colors, Leo Toric ColorsCooperVision, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55… | Permeable Technologies, Inc. | 1995 | — |
| −2 | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens | Aspect Vision Care, Ltd. | 1997 | — |
| −1 | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear | Aspect Vision Care, Ltd. | 1997 | 1 |
| 0 (this device) | K041138 | Leo Colors, Leo Aspheric Colors, Leo Toric Colors | CooperVision, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact LensSummary page 3…) Contact Lenses for daily wear manufactured by CooperVision Manufacturing Ltd. Is equivalent to the Frequency 55 (methafilcon A)Soft (hydrophilic) Contact Lens (K971164) and Frequency Colors and Expressions (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear (K001090) As the m… | 1997 |
| * | K001090 | Methafilcon aSummary page 3…5 (methafilcon A)Soft (hydrophilic) Contact Lens (K971164) and Frequency Colors and Expressions (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear (K001090) As the methafilcon A base lens is produced at the same manufacturing facility as the Frequency 55, Frequency Colors and… | 2000 |
| * | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearSummary page 4…es were demonstrated to be substantially equivalent to the predicate Frequency 55 (methafilcon A)Soft (hydrophilic) Contact Lens (K971164) and (K973063) * The Leo Colors, Lens Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact… | 1997 |
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 9 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K971164.
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.
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?
Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and…
Read the full statement (296 words)
Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less or for occlusive therapy for conditions such as diplopia, amblyopia an extreme photophobia.
When prescribed for Frequent/Planned Replacement Wear, the Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner.
When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041138: Leo Colors, Leo Aspheric Colors, Leo Toric Colors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041138
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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