510(k) Report

510(k) · Cleared

Cleared

Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear

K132854510(k) TraditionalCleared Dec 23, 2013102-day reviewClass II21 CFR 886.5925

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Yung Sheng Optical Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Dec 23, 2013 as substantially equivalent to K020927 (Bausch & Lomb, 2002) after a 102-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.

Decided
Dec 23, 2013
Review
102 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K960926 (1996). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor2015: 2 descendants cleared2014: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK960926 · Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens · Unilens Corp., USA · 1996K020927 · Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens · Bausch & Lomb · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K020927 · Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens · Bausch & Lomb · 2002K960926 · Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens · Unilens Corp., USA · 19960
  1. Root · 2 generations backK960926 Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA · 1996
  2. 1 generation backK020927 Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted…Bausch & Lomb · 2002
  3. This deviceK132854 Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2013
  4. Descendant · cites it directly · 3 of its ownK143052 Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic)…Yung Sheng Optical Co., Ltd. · 2014
  5. Descendant · 2 generations on · 2 of its ownK150630 Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2015
  6. Descendant · 3 generations on · 1 of its ownK232839 Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric…Yung Sheng Optical Co., Ltd. · 2024
  7. Descendant · 4 generations on · 0 of its ownK253352 Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2026
  8. Descendant · cites it directly · 0 of its ownK220045 TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd. · 2022

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014: 12015: 22022: 12024: 12026: 1
2014high 2 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all
  • K143052Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for…Yung Sheng Optical Co., Ltd. · 2014 · cites it directly3descendants
  • K150630Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear…Yung Sheng Optical Co., Ltd. · 2015 · 2 generations on2descendants
  • K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd. · 2024 · 3 generations on1descendant
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation · 2026 · 4 generations on0descendants
  • K220045TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K960926Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA1996—
−1K020927Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact LensBausch & Lomb2002—
0 (this device)K132854Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for…Yung Sheng Optical Co., Ltd.2013—
+1K143052Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens…Yung Sheng Optical Co., Ltd.2014—
+2K150630Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for…Yung Sheng Optical Co., Ltd.2015—
+3K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon)…Yung Sheng Optical Co., Ltd.2024—
+4K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation2026—
+1K220045TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201520
202210
202410
202610
FIG. 1 — Lineage of K132854, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K020927Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens
Summary page 1
…ity Tinted Contact Lens Manufacturer: BAUSCH & LOMB 510(k) Number or Clearance Information: K020927 Yung Sheng Optical Co., Ltd. Eye Secret 38 UVAspheric (polymacon) Soft 510(k) noti…
Bausch & Lomb2002—

Also cleared against K020927: 3 other devices →

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143052Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for…Yung Sheng Optical Co., Ltd.20143
K220045TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd.20220
K143190Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact LensYung Sheng Optical Co., Ltd.20150

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 17 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K143052 (Yung Sheng Optical Co., Ltd., 2014) has gone furthest, with 3 descendants of its own.
  • 3 other devices also cite its predicate K020927.

How does its category compare?

All LPL devices

LPL 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

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

What is it indicated for?

The Eye Secret 38 UV Apsheric (polymacon) Soft (hydrophilic) Contact Lenses for Daily Wear 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.

Indications for use as stated in the FDA summary.

Also cleared against K020927

3 other devices cite the same predicate.

  • K123973Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2013
  • K082883Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily WearI-See Vision Technology, Inc. · 2009
  • K050948Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 2005

More from Yung Sheng Optical Co., Ltd.

10 FDA decisions under this applicant name. See the company

  • K244009Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear)…Yung Sheng Optical Co., Ltd. · 2025
  • K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2024
  • K223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd. · 2023
  • K213983Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd. · 2022
  • K151586Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact LensYung Sheng Optical Co., Ltd. · 2015

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K132854 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132854: Eye Secret 38 UV Aspheric (Polymacon) 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/K132854

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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