# K964612: Vistakon (Genfilcon a) Contact Lens, Clear and with Visibiliity Tint

- Pathway: 510(k) (Traditional)
- Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
- Decided: Jan 30, 1997 after 73 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Optima FW (polymacon) Visibility Tinted Contact Lens: named in the summary without a submission number

## Indications for use
The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and presbyopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less. The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less. The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less. Eye care practitioners may prescribe the lens for single-use disposable wear or for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement (see WEARING SCHEDULE). When prescribed for frequent/planned replacement, the lens may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K964612
Methodology: https://510kreport.com/methodology