510(k) · Cleared
ClearedFrequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens
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 Nov 16, 2004 as substantially equivalent to K971049 (Aspect Vision Care, Ltd., 1997) after a 35-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Nov 16, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950283 (1995). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK950283 Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact LensPermeable Technologies, Inc. · 1995
- 1 generation backK971049 Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1997
- This deviceK042824 Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK123973 Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2013
- Descendant · cites it directly · 1 of its ownK182674 Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens…Largan Medical Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK132714 Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses…Vision Science Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK242916 Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact…Largan Medical Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK142384 DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses…Qualimed Srl · 2014
Most influential descendants
Showing 5 of 5 · See all- K123973Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2013 · cites it directly2descendants
- K182674Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38…Largan Medical Co., Ltd. · 2018 · cites it directly1descendant
- K132714Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and…Vision Science Co., Ltd. · 2014 · 2 generations on1descendant
- K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd. · 2025 · 2 generations on0descendants
- K142384DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950283 | Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact Lens | Permeable Technologies, Inc. | 1995 | — |
| −1 | K971049 | Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and… | Aspect Vision Care, Ltd. | 1997 | — |
| 0 (this device) | K042824 | Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2004 | — |
| +1 | K123973 | Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | 2013 | — |
| +1 | K182674 | Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38… | Largan Medical Co., Ltd. | 2018 | — |
| +2 | K132714 | Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear… | Vision Science Co., Ltd. | 2014 | — |
| +2 | K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | 2025 | — |
| +3 | K142384 | DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and… | Qualimed Srl | 2014 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K971049 | Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Summary page 4…drophilic) contact lens has demonstrated to be substantially equivalent to the predicate post-hydration tinted polymacon soft (hydrophilic) contact lens (K971049). 10. CONCLUSION: The information provided in this 510(k) establishes that the Frequency 38 and Silver 07 (pol… | 1997 |
What descends from it? (5)
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 9 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K123973 (Pegavision Corporation, 2013) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K971049.
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?
Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact 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 that may exhibit astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eye care practitioners may prescribe Frequency 38 (polymacon) Soft (hydrophilic) Contact Lenses for frequent replacement wear, with cleaning, disinfecting, and scheduled replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042824 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042824: Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042824
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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