510(k) · Cleared
ClearedFrequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear
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 Apr 26, 2002 as substantially equivalent to K013649 (Sauflon Pharmaceuticals, Ltd., 2001) and 1 other predicate after a 79-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 26, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951893 (1995). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK951893 Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle…Permeable Technologies, Inc. · 1995
- 3 generations backK971164 Frequency 55 (Methafilcon a) Hydrophilic Contact LensAspect Vision Care, Ltd. · 1997
- 2 generations backK973063 Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. · 1997 · Recalled
- 1 generation backK982997 Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily…Aspect Vision Care, Ltd. · 1999
- This deviceK020392 Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for…CooperVision, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK182247 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses…Vizionfocus, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK243953 Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens…Vizionfocus, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK192225 Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily…Vizionfocus, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See all- K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Vizionfocus, Inc. · 2018 · cites it directly2descendants
- K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)Vizionfocus, Inc. · 2025 · cites it directly0descendants
- K192225Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact LensesVizionfocus, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55… | Permeable Technologies, Inc. | 1995 | — |
| −3 | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens | Aspect Vision Care, Ltd. | 1997 | — |
| −2 | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear | Aspect Vision Care, Ltd. | 1997 | 1 |
| −1 | K982997 | Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear… | Aspect Vision Care, Ltd. | 1999 | — |
| 0 (this device) | 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 | — |
| +1 | K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus, Inc. | 2025 | — |
| +2 | K192225 | Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact… | Vizionfocus, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K013649 | Sauflon 55 UV Soft (Hydrophilic) Contact LensSummary page 1…UVAM (methafilcon A) (Sphere, Asphere and Toric) Soft (hydrophilic) contact lenses for daily wear manufactured by Aspect Vision. The predicate devices were cleared under K013649 and K982997 respectively. The devices were selected as the predicate devices based on the material, intended use and design. 4.… | 2001 |
| * | K982997 | Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and…Summary page 1…ilcon A) (Sphere, Asphere and Toric) Soft (hydrophilic) contact lenses for daily wear manufactured by Aspect Vision. The predicate devices were cleared under K013649 and K982997 respectively. The devices were selected as the predicate devices based on the material, intended use and design. 4. Device Desc… | 1999 |
What descends from it? (3)
2 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)
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 7 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K182247 (Vizionfocus, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K013649.
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?
1. Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear 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. 2. Frequency 55 UV Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia…
Read the full statement (217 words)
1. Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear 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.
2. Frequency 55 UV Toric lenses are indicated for daily wear 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.
FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE.
Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the Frequency 55 UV and Frequency 55 UV Toric 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.
Disposable Wear
When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed fo discard the lenses at each removal.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020392: Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) 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/K020392
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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