# K983912: Vistakon (Lenefilcon a)Contact Lens Clear and Visibility Tint with UV Blocker

- Pathway: 510(k) (Traditional)
- Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
- Decided: Jan 26, 1999 after 84 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) NewVues® (vifilcon A) Soft Contact Lens: named in the summary without a submission number

## Most influential descendants
- K991163: Vistakon (Lenefilcon a) Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with UV Blocker, for Daily Wear (1999), 1 descendant of its own
- K994318: Vistakon (Lenefilcon a)Soft (Hydrophilic)Contact Lens Clear and Visibility Tinted with UV Blocker (2000), 0 descendants of its own

## Indications for use
The VISTAKON Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) 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. The VISTAKON TORIC 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 10.00 D of astigmatism or less. Eye care practitioners may prescribe the lens either for single-use disposable wear or frequent/planned replacement wear with cleaning, disimfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K983912
Methodology: https://510kreport.com/methodology