510(k) · Cleared
ClearedEthos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plexus Optix, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 21, 2020 as substantially equivalent to K040303 (Hydrogel Vision Corporation, 2005) after a 162-day review. Its family tree reaches back 2 generations to 1999. 3 later devices descend from it.
- Decided
- Oct 21, 2020
- Review
- 162 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992692 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK992692 Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 1999
- 1 generation backK040303 59% Extreme H2O (Hioxifilcon a) Soft Contact LensHydrogel Vision Corporation · 2005
- This deviceK201268 Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact…Plexus Optix, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK222885 Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK232649 Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK251095 Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2025
Most influential descendants
Showing 3 of 3 · See all- K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Pegavision Corporation · 2023 · cites it directly2descendants
- K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2024 · 2 generations on1descendant
- K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992692 | Extreme H20 (Hioxifilicon a) Soft Contact Lens | Benz Research and Development Corp. | 1999 | — |
| −1 | K040303 | 59% Extreme H2O (Hioxifilcon a) Soft Contact Lens | Hydrogel Vision Corporation | 2005 | — |
| 0 (this device) | K201268 | Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59%… | Plexus Optix, Inc. | 2020 | — |
| +1 | K222885 | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | Pegavision Corporation | 2023 | — |
| +2 | K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | 2024 | — |
| +3 | K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K040303 | 59% Extreme H2O (Hioxifilcon a) Soft Contact LensSummary page 4…Lens. Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN FDA Classification: Class II K040303 Hydrogel Vision Corporation Predicate Device Name: 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for… | 2005 |
| † | K992692 | Extreme H20 (Hioxifilicon a) Soft Contact Lens | 1999 |
| † | K983773 | Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact Lens | 1998 |
| † | K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft… | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222885 | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | 2023 | 2 |
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 21 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K222885 (Pegavision Corporation, 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K040303.
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. 2020, 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?
Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. Ethos Aquell (Hioxifilcon A) Toric…
Read the full statement (122 words)
Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Ethos Aquell (Hioxifilcon A) Toric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.
The lenses are intended for single-use disposable wear.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201268: Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201268
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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