# K222954: Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Innova Vision, Inc.
- Decided: Mar 13, 2023 after 167 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083288: Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker, Innova Vision, Inc. (2009) Summary page 5.
- K213119: Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens, Innova Vision, Inc. (2022) Summary page 6.

## Most influential descendants
- K240519: Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens (2024), 0 descendants of its own

## Indications for use
Sphere/Asphere Innova Vision Sphere and Asphere (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Toric Innova Vision Toric (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Multifocal Innova Vision Multifocal (Etafilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric Innova Vision Multifocal Toric (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters. Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

Source page: https://510kreport.com/device/K222954
Methodology: https://510kreport.com/methodology