510(k) · Cleared
ClearedPegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pegavision Corporation · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jul 2, 2025 as substantially equivalent to K052560 (CooperVision, Inc., 2005) after a 197-day review. Its family tree reaches back 5 generations to 1981. 2 later devices descend from it.
- Decided
- Jul 2, 2025
- Review
- 197 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to P810005 (1981). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 4 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 3 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 2 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 1 generation backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- This deviceK243868 Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2025
- Descendant · cites it directly · 0 of its ownK261299 Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2026
- Descendant · cites it directly · 0 of its ownK252385 Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2026
Most influential descendants
Showing 2 of 2 · See all- K261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation · 2026 · cites it directly0descendants
- K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −4 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −3 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −2 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −1 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| 0 (this device) | K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2025 | — |
| +1 | K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2026 | — |
| +1 | K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 K213119 Innova Vision Hydrogel (Hioxifilcon A) Soft…score 15.9 · 3 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 |
|---|---|---|---|
| * | K052560 | Biofinity (Comfilcon a) Soft Contact LensSummary page 6…LPL Lens. Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN FDA Classification: Class II Predicate Device: K052560, Biofinity (Comfilcon A) Soft Contact Lens Description of Device Pegavision (Toufilcon B) Dai… | 2005 |
| † | K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | 2024 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 44 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K261299 (Pegavision Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 14 other devices also cite its predicate K052560.
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. 2025, 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?
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…
Read the full statement (294 words)
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.OOD to -12.OOD.
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.
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 or hyperopia) with presbyopia in aphakic or non-aphakic person with non-diseased eyes who may have +0.25D to +3.OOD of ADD powers or less. The lens may be prescribed in spherical powers ranging from +6.OOD to -12.25D. 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.
https://510kreport.com/device/K243868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243868: 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/K243868
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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