# K192225: Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Vizionfocus, Inc.
- Decided: Dec 9, 2019 after 115 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). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 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 5.
- K050157: Maxsight (Polymacon) Sport-Tinted Contact Lens, Bausch & Lomb, Inc. (2005) Summary page 5.

## Indications for use
The Legacy (ocufilcon D) Performance-Tinted SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The Legacy (ocufilcon D) Performance-Tinted TORIC Soft Contact Lenses for daily wear 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 Legacy ( ocufilcon D) Performance-Tinted MUL TIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with nondiseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. 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/K192225
Methodology: https://510kreport.com/methodology