# K243953: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)

- Pathway: 510(k) (Traditional)
- Applicant: Vizionfocus, Inc.
- Decided: Apr 10, 2025 after 108 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: 6 generations back to K951893 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182247: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color), Vizionfocus, Inc. (2018) Summary page 7.
- K020392: Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear, CooperVision, Inc. (2002) Summary page 9.
- K150293: EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D), I-See Vision Technology, Inc. (2015) Summary page 9.

## Indications for use
The SPHERICAL/ ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The TORIC Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The MULTl FOCAL Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients. Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

Source page: https://510kreport.com/device/K243953
Methodology: https://510kreport.com/methodology