510(k) · Cleared
ClearedFrequency 55 (Methafilcon a) Hydrophilic Contact Lens
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 May 21, 1997 as substantially equivalent to K951893 (Permeable Technologies, Inc., 1995) and 1 other predicate after a 51-day review. Its family tree reaches back 1 generation to 1995. 14 later devices descend from it.
- Decided
- May 21, 1997
- Review
- 51 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951893 (1995). 2 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK951893 Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle…Permeable Technologies, Inc. · 1995
- This deviceK971164 Frequency 55 (Methafilcon a) Hydrophilic Contact LensAspect Vision Care, Ltd. · 1997
- Descendant · cites it directly · 12 of its ownK973063 Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. · 1997 · Recalled
- Descendant · 2 generations on · 7 of its ownK013649 Sauflon 55 UV Soft (Hydrophilic) Contact LensSauflon Pharmaceuticals, Ltd. · 2001
- Descendant · 2 generations on · 6 of its ownK982997 Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily…Aspect Vision Care, Ltd. · 1999
- Descendant · 3 generations on · 3 of its ownK020392 Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for…CooperVision, Inc. · 2002
- Descendant · 4 generations on · 2 of its ownK182247 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses…Vizionfocus, Inc. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K973063Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. · 1997 · cites it directly12descendants
- K013649Sauflon 55 UV Soft (Hydrophilic) Contact LensSauflon Pharmaceuticals, Ltd. · 2001 · 2 generations on7descendants
- K982997Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and…Aspect Vision Care, Ltd. · 1999 · 2 generations on6descendants
- K020392Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily WearCooperVision, Inc. · 2002 · 3 generations on3descendants
- K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Vizionfocus, Inc. · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55… | Permeable Technologies, Inc. | 1995 | — |
| 0 (this device) | 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 |
| +2 | K013649 | Sauflon 55 UV Soft (Hydrophilic) Contact Lens | Sauflon Pharmaceuticals, Ltd. | 2001 | — |
| +2 | K982997 | Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear… | Aspect Vision Care, Ltd. | 1999 | — |
| +3 | K020392 | Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear | CooperVision, Inc. | 2002 | — |
| +4 | K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted… | Vizionfocus, Inc. | 2018 | — |
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 |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55 (Ocufilcon D)… Our OCR of the scanned summary read K851893, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “LifeStyle FREQUENCY Progressive (methafilcon A) Hydrophilic…”. | 1995 |
| * | K963011 | Lifestyle Frequency Progressive (Methafilcon a) Multifocal Hydrophilic Contact Lenses…Summary page 1…ackaging, quality control/quality assurance, established shelf life data, shelf life protocol) necessary to manufacture the devices, which are the subject of K851893 and K963011. In addition, Aspect Vision Care, Ltd. will manufacture these devices at the same manufacturing location as the predicate device… | 1996 |
What descends from it? (14)
See all 143 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K973063 (Aspect Vision Care, Ltd., 1997) has gone furthest, with 12 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.
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/K971164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971164: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971164
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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