# K222885: Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

- Pathway: 510(k) (Traditional)
- Applicant: Pegavision Corporation
- Decided: May 31, 2023 after 250 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: 4 generations back to K992692 (1999). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201268: Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), Plexus Optix, Inc. (2020) Summary page 4.
- K213119: Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens, Innova Vision, Inc. (2022) Summary page 4.

## Most influential descendants
- 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
Sphere and Asphere Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Sphere and Asphere designs 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. Toric Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Toric designs 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. Multifocal Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 -12.25 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.

Source page: https://510kreport.com/device/K222885
Methodology: https://510kreport.com/methodology