# K153305: EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Eyeyon Medical
- Decided: Apr 8, 2016 after 144 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: 5 generations back to P810005 (1981). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150590: CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,, Contamac, Ltd. (2015) Summary page 6.
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses, Ciba Vision Corporation (2008) Summary page 6.

## Indications for use
The EyeYon (hioxifilcon D) Spherical soft contact lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The EyeYon (hioxifilcon D) Toric soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 4.00 diopters (D) or less of astigmatism. The EyeYon (hioxifilcon D) Multifocal soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia, hyperopia, and/or presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 0.75 diopters of astigmatism. The EyeYon (hioxifilcon D) Multifocal Toric soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 4.00 diopters (D) or less of refractive and/or corneal astigmatism. The Hyper-CL™ (hioxifilcon D) Therapeutic soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia in phakic or aphakic persons with non-diseased eyes. The lenses may be prescribed for therapeutic use to promote corneal healing and relieve corneal pain by protecting the cornea during the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K153305
Methodology: https://510kreport.com/methodology