510(k) · Cleared
ClearedLargan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Largan Medical Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 13, 2018 as substantially equivalent to K042824 (CooperVision, Inc., 2004) after a 48-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Nov 13, 2018
- Review
- 48 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950283 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK950283 Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact LensPermeable Technologies, Inc. · 1995
- 2 generations backK971049 Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1997
- 1 generation backK042824 Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2004
- This deviceK182674 Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens…Largan Medical Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK242916 Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact…Largan Medical Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950283 | Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact Lens | Permeable Technologies, Inc. | 1995 | — |
| −2 | 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 | — |
| 0 (this device) | K182674 | Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38… | Largan Medical Co., Ltd. | 2018 | — |
| +1 | K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K042824 | Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensSummary page 4…(hydrophilic) Contact Lens Manufacturer CooperVision, Inc. 510(k) Number K042824 Product Code LPL Page 1… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | 2025 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K242916 (Largan Medical Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042824.
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. 2018, this device’s year, is highlighted.
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 Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity. The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily…
Read the full statement (241 words)
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.75 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182674: Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182674
Report an extraction error
Are you the manufacturer?
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