510(k) · Cleared
ClearedLargan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) 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 Jun 25, 2018 as substantially equivalent to K993252 (CooperVision, Inc., 1999) after a 47-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jun 25, 2018
- Review
- 47 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K951893 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK951893 Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle…Permeable Technologies, Inc. · 1995
- 4 generations backK971164 Frequency 55 (Methafilcon a) Hydrophilic Contact LensAspect Vision Care, Ltd. · 1997
- 3 generations backK973063 Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. · 1997 · Recalled
- 2 generations backK982997 Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily…Aspect Vision Care, Ltd. · 1999
- 1 generation backK993252 Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55…CooperVision, Inc. · 1999
- This deviceK181230 Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact…Largan Medical Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55… | Permeable Technologies, Inc. | 1995 | — |
| −4 | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens | Aspect Vision Care, Ltd. | 1997 | — |
| −3 | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear | Aspect Vision Care, Ltd. | 1997 | 1 |
| −2 | K982997 | Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear… | Aspect Vision Care, Ltd. | 1999 | — |
| −1 | K993252 | Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV… | CooperVision, Inc. | 1999 | — |
| 0 (this device) | K181230 | Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan… | Largan Medical Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K993252 | Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to BE…Summary page 4…55 UV. Frequency 55 Aspheric, Encore, Encore Toric. CooperFlex and Onevue (methafilcon A) Soft (hydrophilic) Contact Lens Manufacturer CooperVision, Inc. 510(k) Number K993252 Product Code MVN: LPL 1.5 Device Description The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens is in hemi… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 1.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
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 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens is a Daily Wear Soft (hydrophilic) Contact Lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or 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 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is…
Read the full statement (246 words)
The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens is a Daily Wear Soft (hydrophilic) Contact Lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or 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 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated 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 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated 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 +0.25 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181230: Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) 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/K181230
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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