510(k) · Cleared
Recalled · 2003Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspect Vision Care, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Aug 26, 1997 as substantially equivalent to K971164 (Aspect Vision Care, Ltd., 1997) after an 8-day review. Its family tree reaches back 2 generations to 1995. 12 later devices descend from it. It has been recalled once.
- Decided
- Aug 26, 1997
- Review
- 8 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951893 (1995). 3 ancestors in all. 12 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK951893 Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle…Permeable Technologies, Inc. · 1995
- 1 generation backK971164 Frequency 55 (Methafilcon a) Hydrophilic Contact LensAspect Vision Care, Ltd. · 1997
- This deviceK973063 Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. · 1997
- Descendant · cites it directly · 7 of its ownK013649 Sauflon 55 UV Soft (Hydrophilic) Contact LensSauflon Pharmaceuticals, Ltd. · 2001
- Descendant · cites it directly · 6 of its ownK982997 Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily…Aspect Vision Care, Ltd. · 1999
- Descendant · 2 generations on · 3 of its ownK020392 Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for…CooperVision, Inc. · 2002
- Descendant · 3 generations on · 2 of its ownK182247 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses…Vizionfocus, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK133735 Eye Secret 55 UV Aspheric (Methafilcon a) Soft (Hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K013649Sauflon 55 UV Soft (Hydrophilic) Contact LensSauflon Pharmaceuticals, Ltd. · 2001 · cites it directly7descendants
- K982997Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and…Aspect Vision Care, Ltd. · 1999 · cites it directly6descendants
- K020392Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily WearCooperVision, Inc. · 2002 · 2 generations on3descendants
- K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Vizionfocus, Inc. · 2018 · 3 generations on2descendants
- K133735Eye Secret 55 UV Aspheric (Methafilcon a) Soft (Hydrophilic) Contact LensYung Sheng Optical Co., Ltd. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55… | Permeable Technologies, Inc. | 1995 | — |
| −1 | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens | Aspect Vision Care, Ltd. | 1997 | — |
| 0 (this device) | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear | Aspect Vision Care, Ltd. | 1997 | — |
| +1 | K013649 | Sauflon 55 UV Soft (Hydrophilic) Contact Lens | Sauflon Pharmaceuticals, Ltd. | 2001 | — |
| +1 | 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 | — |
| +3 | K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted… | Vizionfocus, Inc. | 2018 | — |
| +2 | K133735 | Eye Secret 55 UV Aspheric (Methafilcon a) Soft (Hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 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? (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 |
|---|---|---|---|
| * | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact LensSummary page 1…(methafilcon A) Hydrophilic Contact Lens for Daily Wear are equivalent to the FREQUENCY 55™ (methafilcon A) Hydrophilic Contact Lens for Daily Wear cleared pursuant to K971164. FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear are substantially equivalent to the indications for use, m… | 1997 |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013649 | Sauflon 55 UV Soft (Hydrophilic) Contact Lens | 2001 | 7 |
| K982997 | Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and… | 1999 | 6 |
| K993252 | Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to BE… | 1999 | 1 |
| K041138 | Leo Colors, Leo Aspheric Colors, Leo Toric Colors | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2003 | Not classified | Z-0978-03 | Other | The actual sphere power of the lens is lower than the labeled value. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K013649 (Sauflon Pharmaceuticals, Ltd., 2001) has gone furthest, with 7 descendants of its own.
- 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?
The FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.
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/K973063 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973063: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973063
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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