510(k) Report

510(k) · Cleared

Cleared

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

K252385510(k) TraditionalCleared Mar 13, 2026225-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

Pegavision Corporation · LPL Lenses, Soft Contact, Daily Wear

Cleared on Mar 13, 2026 as substantially equivalent to K243868 (Pegavision Corporation, 2025) after a 225-day review. Its family tree reaches back 6 generations to 1981.

Decided
Mar 13, 2026
Review
225 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to P810005 (1981). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1984: 1 other ancestor2001: 1 other ancestorReference device: K232649 · Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses · Pegavision Corporation · 2024P810005 · Weicon (R) (Tefilicon) Hydrophilic Contact Lens · Ciba Vision Care · 1981K970746 · SEE3 (Lotrafilcon a) Soft Contact Lens · Ciba Vision Corporation · 1997K020139 · Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design · Ciba Vision Corporation · 2002K033919 · Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs · Ciba Vision Corporation · 2004 · recalledK052560 · Biofinity (Comfilcon a) Soft Contact Lens · CooperVision, Inc. · 2005 · recalledK243868 · Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses · Pegavision Corporation · 202519801990200020102020
Other ancestors, by generation 4 generations back: 1 other ancestor5 generations back: 1 other ancestor K243868 · Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses · Pegavision Corporation · 2025K052560 · Biofinity (Comfilcon a) Soft Contact Lens · CooperVision, Inc. · 2005 · recalledK033919 · Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs · Ciba Vision Corporation · 2004 · recalledK020139 · Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design · Ciba Vision Corporation · 2002K970746 · SEE3 (Lotrafilcon a) Soft Contact Lens · Ciba Vision Corporation · 1997P810005 · Weicon (R) (Tefilicon) Hydrophilic Contact Lens · Ciba Vision Care · 1981−50
  1. Root · 6 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
  2. 5 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
  3. 4 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
  4. 3 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
  5. 2 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
  6. 1 generation backK243868 Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2025
  7. This deviceK252385 Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6P810005Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care1981—
−5K970746SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation1997—
−4K020139Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation2002—
−3K033919Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal…Ciba Vision Corporation20041
−2K052560Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc.20051
−1K243868Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation2025—
0 (this device)K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
200110
FIG. 1 — Lineage of K252385, 1981–2026Source: 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
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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
*K243868Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…
Summary page 5
…Lens. Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN FDA Classification: Class II Predicate Device: K243868, Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses Pe…
Pegavision Corporation2025—
†K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation2024—

Also cleared against K243868: 1 other device →

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 45 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
  • 4 of the 8 ancestors have a recall of any class.
  • 1 other device also cites its predicate K243868.

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. 2026, 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?

Sphere/ Asphere Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with…

Read the full statement (295 words)

Sphere/ Asphere

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D.

Toric

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D.

Multifocal

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition of +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.

Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Indications for use as stated in the FDA summary.

Also cleared against K243868

1 other device cites the same predicate.

  • K261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft…Pegavision Corporation · 2026

More from Pegavision Corporation

14 FDA decisions under this applicant name. See the company

  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026
  • K261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft…Pegavision Corporation · 2026
  • K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2025
  • K243868Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft…Pegavision Corporation · 2025
  • K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2024

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/K252385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K252385: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252385

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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