510(k) · Cleared
ClearedEasy Day (Methafilcon a) 1-Day Soft (Hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Horien Contact Lens Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Aug 30, 2013 as substantially equivalent to K000384 (CooperVision, Inc., 2000) after a 148-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 30, 2013
- Review
- 148 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000384 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000384 Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview…CooperVision, Inc. · 2000
- This deviceK130931 Easy Day (Methafilcon a) 1-Day Soft (Hydrophilic) Contact LensJiangsu Horien Contact Lens Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000384 | Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, Cooperflex | CooperVision, Inc. | 2000 | — |
| 0 (this device) | K130931 | Easy Day (Methafilcon a) 1-Day Soft (Hydrophilic) Contact Lens | Jiangsu Horien Contact Lens Co., Ltd. | 2013 | — |
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 |
|---|---|---|---|
| * | K000384 | Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, CooperflexSummary page 1…Predicate Device: FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVUE, COOPERELEX (methafilcon A) Soft (hydrophilic) Contact Lens cleared via K000384 COOPERVISION, INC. Indications for Use EASY DAY (mnethafilcon A) 1-Day Soft ( Hydrophilic) Contact Lens is indicated fo… | 2000 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K000384.
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. 2013, 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?
EASY DAY (methafilcon A) 1-Day Soft ( Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.75 diopters that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0 - - 12.OOD.
The lens is indicated for single use daily disposable wear and patients are instructed to discard the lens after each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130931: Easy Day (Methafilcon a) 1-Day Soft (Hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130931
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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