510(k) · Cleared
ClearedEye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon 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. · MVN Lens, Contact, (Disposable)
Cleared on Jun 15, 2015 as substantially equivalent to K143052 (Yung Sheng Optical Co., Ltd., 2014) after a 96-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.
- Decided
- Jun 15, 2015
- Review
- 96 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960926 (1996). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK960926 Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA · 1996
- 3 generations backK020927 Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted…Bausch & Lomb · 2002
- 2 generations backK132854 Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2013
- 1 generation backK143052 Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic)…Yung Sheng Optical Co., Ltd. · 2014
- This deviceK150630 Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK232839 Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric…Yung Sheng Optical Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK253352 Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2026
Most influential descendants
Showing 2 of 2 · See all- K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd. · 2024 · cites it directly1descendant
- K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960926 | Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens | Unilens Corp., USA | 1996 | — |
| −3 | K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens | Bausch & Lomb | 2002 | — |
| −2 | K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for… | Yung Sheng Optical Co., Ltd. | 2013 | — |
| −1 | K143052 | Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens… | Yung Sheng Optical Co., Ltd. | 2014 | — |
| 0 (this device) | K150630 | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for… | Yung Sheng Optical Co., Ltd. | 2015 | — |
| +1 | K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon)… | Yung Sheng Optical Co., Ltd. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 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 MVN? 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 MVN device
- #1 K261812 HOYA Illumina (sorafilcon A) Daily Disposable…score 14.0 · 9 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 |
|---|---|---|---|
| * | K143052 | Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for…Summary page 4…e: Soft (hydrophilic) Contact Lens for Daily Wear; Manufacturer: Yung Sheng Optical Co., Ltd. 510(k) Number or Clearance Information: K143052 K150630… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft… | 2024 | 1 |
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 19 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K232839 (Yung Sheng Optical Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MVN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MVN
Too few MVN 510(k)s in any year since 2007 to give a median.
Recalls per year · MVN
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVN
22in 2025
MAUDE reports naming product code MVN, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 1 | — | 2 | 35 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 2 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 23 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 2 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against…
Read the full statement (121 words)
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
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 system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150630: Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon 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/K150630
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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