510(k) · Cleared
ClearedEye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yung Sheng Optical Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Sep 2, 2022 as substantially equivalent to K061948 (CooperVision, Inc., 2006) and 1 other predicate after a 256-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Sep 2, 2022
- Review
- 256 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003136 (2001). 14 ancestors in all, the oldest K952152 (1995). No later device cites it as a predicate yet.
- Root · 6 generations backK003136 Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily…Ocular Sciences Puerto Rico, Inc. · 2001
- 5 generations backK020389 Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact LensOcular Sciences · 2002
- 4 generations backK061948 Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006 · Recalled
- 3 generations backK110099 Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear…CooperVision, Inc. · 2011
- 2 generations backK112302 Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal…CooperVision, Inc. · 2011
- 1 generation backK162223 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd · 2017
- This deviceK213983 Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003136 | Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft… | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| −5 | K020389 | Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens | Ocular Sciences | 2002 | — |
| −4 | K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens | CooperVision, Inc. | 2006 | 1 |
| −3 | K110099 | Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft… | CooperVision, Inc. | 2011 | — |
| −2 | K112302 | Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear… | CooperVision, Inc. | 2011 | — |
| −1 | K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | Supervision Optimax Sdn Bhd | 2017 | — |
| 0 (this device) | K213983 | Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for… | Yung Sheng Optical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensSummary page 4…duct Code: LPL for Lenses, Soft Contact, Daily Wear MVN for Lens, Contact, (Disposable) 510(k) Number: K061948 Predicate Device Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Name: Contact… | 2006 |
| * | K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Summary page 4…duct Code: LPL for Lenses, Soft Contact, Daily Wear MVN for Lens, Contact, (Disposable) 510(k) Number: K162223 2 of 6 Yung She… | 2017 |
| † | K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear | 2013 |
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 21 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 4 other devices also cite its predicate K061948.
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. 2022, 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 Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting 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/K213983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213983: Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213983
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