510(k) · Cleared
ClearedEye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens
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 Dec 16, 2014 as substantially equivalent to K132854 (Yung Sheng Optical Co., Ltd., 2013) after a 54-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.
- Decided
- Dec 16, 2014
- Review
- 54 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960926 (1996). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK960926 Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA · 1996
- 2 generations backK020927 Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted…Bausch & Lomb · 2002
- 1 generation backK132854 Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2013
- This deviceK143052 Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic)…Yung Sheng Optical Co., Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK150630 Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK232839 Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric…Yung Sheng Optical Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK253352 Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2026
Most influential descendants
Showing 3 of 3 · See all- K150630Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear…Yung Sheng Optical Co., Ltd. · 2015 · cites it directly2descendants
- K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd. · 2024 · 2 generations on1descendant
- K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960926 | Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens | Unilens Corp., USA | 1996 | — |
| −2 | K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens | Bausch & Lomb | 2002 | — |
| −1 | K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for… | Yung Sheng Optical Co., Ltd. | 2013 | — |
| 0 (this device) | K143052 | Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens… | Yung Sheng Optical Co., Ltd. | 2014 | — |
| +1 | K150630 | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for… | Yung Sheng Optical Co., Ltd. | 2015 | — |
| +2 | K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon)… | Yung Sheng Optical Co., Ltd. | 2024 | — |
| +3 | K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily WearSummary page 4…r Daily Wear Manufacturer: Yung Sheng Optical Co., Ltd. 510(k) Number or Clearance Information: K132854 5.2… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150630 | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear… | 2015 | 2 |
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 18 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K150630 (Yung Sheng Optical Co., Ltd., 2015) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K132854.
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. 2014, 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 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The Eye Secret 38 UV Aspheric Color…
Read the full statement (163 words)
The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens help protect against transmission of harmful UV radiation to the cornea and into the eye.
For Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, the eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143052: Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color (polymacon) 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/K143052
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