# K073485: Vistakon (Narafilcon) a Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Vision Care, Inc.
- Decided: Mar 3, 2008 after 82 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: 1 generation back to K962804 (1996). 2 ancestors in all.
30 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032340: Vistakon (Galyfilcon a) Soft Contact Lens, Johnson & Johnson Vision Care, Inc. (2003) Summary page 1.
- K962804: Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker, Vistakon, Johnson & Johnson Vision Products, Inc. (1996) Summary page 1.

## Most influential descendants
- K100349: Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV Blocker (2010), 13 descendants of its own
- K113168: Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal Toric (2012), 12 descendants of its own
- K160344: Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 (2016), 8 descendants of its own
- K130331: Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (2013), 6 descendants of its own
- K182902: Precision1 (2018), 4 descendants of its own

## Indications for use
The VISTAKON® (narafilcon A) Soft Contact Lens (spherical) is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.000 or less of astigmatism. The VISTAKON® (narafilcon A) Multifocal Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less. The VISTAKON® (narafilcon A)Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism. The VISTAKON® (narafilcon A) Multifocal-Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. VISTAKON® (narafilcon A) Contact Lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye. The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.

Source page: https://510kreport.com/device/K073485
Methodology: https://510kreport.com/methodology