# K962804: Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker

- Pathway: 510(k) (Traditional)
- Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
- Decided: Oct 1, 1996 after 75 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.
97 later devices descend from it; 12 cite it directly.
0 of 98 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 no predicate by number.

## Most influential descendants
- K073485: Vistakon (Narafilcon) a Soft Contact Lens (2008), 30 descendants of its own
- K020927: Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens (2002), 26 descendants of its own
- K991134: Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with UV Blocker, for Daily Wear (1999), 20 descendants of its own
- K051129: Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear (2005), 18 descendants of its own
- K994324: Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility Tinted with UV Blocker (2000), 17 descendants of its own

## Indications for use
The ACUVUE 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 ACUVUE 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 ACUVUE 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 either single-use disposable wear or 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 disinfection system only.

Source page: https://510kreport.com/device/K962804
Methodology: https://510kreport.com/methodology