# K972454: Oxycor (Balafilcon a) Visibility Tinted Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Aug 8, 1997 after 38 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
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BAUSCH & LOMB® Premier 90 (balafilcon A) Contact Lens (clear lens): named in the summary without a submission number
- (no number) BAUSCH & LOMB Optima™ 38 (polymacon) Visibility Tinted Contact Lens: named in the summary without a submission number

## Most influential descendants
- K050948: Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact Lens (2005), 13 descendants of its own
- K122575: Bausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb Purevision Toric (Balafilcon a) VI (2012), 10 descendants of its own
- K131208: Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon a) Contact Lens for Presbyopia, (2013), 9 descendants of its own
- K132715: Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens (2013), 3 descendants of its own
- K223397: HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens (2024), 1 descendant of its own

## Indications for use
The BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens is indicated for vision correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to - 20.00D. The lens may be disinfected using either a heat or chemical disinfection system. Eye Care Practitioners may prescribe the lens for traditional or frequent/planned replacement wearing schedule, with cleaning, disinfection and scheduled replacement of the lens.

Source page: https://510kreport.com/device/K972454
Methodology: https://510kreport.com/methodology