510(k) · Cleared
ClearedFrequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)
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 K963001 (Permeable Technologies, Inc., 1997) and 2 other predicates after a 61-day review. Its family tree reaches back 1 generation to 1995. 11 later devices descend from it.
- Decided
- May 21, 1997
- Review
- 61 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K950283 (1995). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK950283 Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact LensPermeable Technologies, Inc. · 1995
- This deviceK971049 Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1997
- Descendant · cites it directly · 5 of its ownK042824 Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK984259 Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear…Cl-Tinters · 1999
- Descendant · 2 generations on · 2 of its ownK123973 Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2013
- Descendant · 2 generations on · 2 of its ownK992950 Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK182674 Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens…Largan Medical Co., Ltd. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K042824Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2004 · cites it directly5descendants
- K984259Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Cl-Tinters · 1999 · cites it directly4descendants
- K123973Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2013 · 2 generations on2descendants
- K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999 · 2 generations on2descendants
- K182674Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38…Largan Medical Co., Ltd. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950283 | Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact Lens | Permeable Technologies, Inc. | 1995 | — |
| 0 (this device) | K971049 | Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and… | Aspect Vision Care, Ltd. | 1997 | — |
| +1 | K042824 | Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2004 | — |
| +1 | K984259 | Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and… | Cl-Tinters | 1999 | — |
| +2 | K123973 | Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | 2013 | — |
| +2 | K992950 | Custom Prosthetic (Hefilcon a) Soft Lens | Prosthetic Soft Lens Corp. | 1999 | — |
| +2 | K182674 | Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38… | Largan Medical Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963001 | Lifestyle 4-Vue (Polymacon) Hydrophilic Multifocal Contact Lens for Daily Wear Our OCR of the scanned summary read K863001, 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 4-Vue (polymacon) Hydrophilic Contact Lens for Daily Wear…”. | 1997 |
| * | K950283 | Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact LensSummary page 1…ckaging, quality control/quality assurance, established shelf life data, shelf life protocol) necessary to manufacture the devices, which are the subject of K8683001 and K950283. Aspect Vision Care, Ltd. has aiso received from The LifeStyle Company, Inc. the right to referencs its premarket notifications,… | 1995 |
| Kept off the family tree | K850283 | LifeStyle 4-Vue (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and… Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…are the subject of K8683001 and K950283. Aspect Vision Care, Ltd. has aiso received from The LifeStyle Company, Inc. the right to referencs its premarket notifications, K850283 and K983001. In addition, Aspect Vision Care, Ltd.. will manufacture these devices at the same manufacturing location as the pred… | |
| * | K963001 | Lifestyle 4-Vue (Polymacon) Hydrophilic Multifocal Contact Lens for Daily Wear Our OCR of the scanned summary read K983001, 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 4-Vue (polymacon) Hydrophilic Contact Lens for Daily Wear…”. | 1997 |
What descends from it? (11)
See all 112 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, K042824 (CooperVision, Inc., 2004) has gone furthest, with 5 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 38™ (polymacon) 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 heat, 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/K971049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971049: Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971049
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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