510(k) · Cleared
ClearedPegavision (Hioxifilcon A) Daily Disposable Soft 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 Sep 17, 2025 as substantially equivalent to K232649 (Pegavision Corporation, 2024) after a 160-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Sep 17, 2025
- Review
- 160 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K992692 (1999). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK992692 Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 1999
- 5 generations backK051430 Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and…Hydrogel Vision Corporation · 2005
- 4 generations backK153766 Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily…INTEROJO, Inc. · 2016
- 3 generations backK213119 Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2022
- 2 generations backK222885 Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2023
- 1 generation backK232649 Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2024
- This deviceK251095 Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K992692 | Extreme H20 (Hioxifilicon a) Soft Contact Lens | Benz Research and Development Corp. | 1999 | — |
| −5 | K051430 | Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric) | Hydrogel Vision Corporation | 2005 | — |
| −4 | K153766 | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear… | INTEROJO, Inc. | 2016 | — |
| −3 | K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | Innova Vision, Inc. | 2022 | — |
| −2 | K222885 | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | Pegavision Corporation | 2023 | — |
| −1 | K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | 2024 | — |
| 0 (this device) | K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2020 | 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 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 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 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 |
|---|---|---|---|
| * | K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesSummary page 5…925, Product Code LPL Lens. Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN FDA Classification: Class II Predicate Device: K232649, Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses Des… | 2024 |
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 26 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- None of the 8 ancestors has a recall.
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 (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Sphere and Asphere designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. Pegavision (Hioxifilcon A) Daily…
Read the full statement (200 words)
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Sphere and Asphere designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.50 to -3.50 diopters.
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.OOD. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
The lenses are intended for single-use disposable wear.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251095: Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251095
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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