# K201268: Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

- Pathway: 510(k) (Traditional)
- Applicant: Plexus Optix, Inc.
- Decided: Oct 21, 2020 after 162 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992692 (1999). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040303: 59% Extreme H2O (Hioxifilcon a) Soft Contact Lens, Hydrogel Vision Corporation (2005) Summary page 4.

## Most influential descendants
- K222885: Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (2023), 2 descendants of its own
- K232649: Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (2024), 1 descendant of its own
- K251095: Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K201268
Methodology: https://510kreport.com/methodology