510(k) Report

510(k) · Cleared

Cleared

Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens

K960926510(k) TraditionalCleared Apr 10, 199635-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

Unilens Corp., USA · LPL Lenses, Soft Contact, Daily Wear

Cleared on Apr 10, 1996 after a 35-day review. The FDA summary names no predicate by number. 28 later devices descend from it.

Decided
Apr 10, 1996
Review
35 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

28 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2002: 1 descendant cleared2009: 1 descendant cleared2013: 4 descendants cleared2005: 1 descendant cleared2016: 2 descendants cleared2014: 3 descendants cleared2015: 3 descendants cleared2022: 1 descendant cleared2023: 3 descendants cleared2024: 2 descendants cleared2018: 1 descendant cleared2026: 3 descendants cleared2021: 1 descendant cleared2025: 1 descendant clearedReference device: K941836 · Unilens 38 Soft Aspheric Contact Lens · Unilens Corp., USA · 19941995200020052010201520202025
  1. This deviceK960926 Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA · 1996
  2. Descendant · cites it directly · 26 of its ownK020927 Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted…Bausch & Lomb · 2002
  3. Descendant · 2 generations on · 13 of its ownK050948 Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 2005
  4. Descendant · 3 generations on · 9 of its ownK131208 Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb…Bausch & Lomb, Inc. · 2013
  5. Descendant · 2 generations on · 6 of its ownK132854 Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2013
  6. Descendant · 3 generations on · 3 of its ownK143052 Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic)…Yung Sheng Optical Co., Ltd. · 2014

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2002: 12005: 12009: 12011: 12013: 42014: 32015: 32016: 22018: 12021: 12022: 12023: 32024: 22025: 12026: 3
2002high 4 (2013) · low 0 (2003)2026

Most influential descendants

Showing 5 of 28 · See all
  • K020927Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact LensBausch & Lomb · 2002 · cites it directly26descendants
  • K050948Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 2005 · 2 generations on13descendants
  • K131208Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon…Bausch & Lomb, Inc. · 2013 · 3 generations on9descendants
  • K132854Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd. · 2013 · 2 generations on6descendants
  • K143052Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for…Yung Sheng Optical Co., Ltd. · 2014 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960926Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA1996—
+1K020927Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact LensBausch & Lomb2002—
+2K050948Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc.2005—
+3K131208Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort…Bausch & Lomb, Inc.2013—
+2K132854Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for…Yung Sheng Optical Co., Ltd.2013—
+3K143052Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens…Yung Sheng Optical Co., Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200510
200910
201110
201340
201430
201530
201620
201810
202110
202210
202330
202420
202510
202630
FIG. 1 — Lineage of K960926, 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?

The FDA summary names no predicate by number.

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K020927Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact LensBausch & Lomb200226
K110452Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens…Unilens Corp., USA20110

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?

  • Of its descendants, K020927 (Bausch & Lomb, 2002) has gone furthest, with 26 descendants of its own.

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.

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—

More from Unilens Corp., USA

38 FDA decisions under this applicant name. See the company

  • P890040/S008Soft-Form 55EW; LL-55; Softcon EW2Unilens Corp., USA · 2016
  • K142851CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact LensUnilens Corp., USA · 2014
  • P890040/S007Sof-Form 55 EW, LL-55, Softcon EW 2Unilens Corp., USA · 2013
  • K121652Cvue Advanced Hydra VueUnilens Corp., USA · 2012
  • K110452Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue…Unilens Corp., USA · 2011

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/K960926 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960926: Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960926

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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