# K100349: Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV Blocker

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Vision Care, Inc.
- Decided: May 21, 2010 after 98 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: 2 generations back to K962804 (1996). 3 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073485: Vistakon (Narafilcon) a Soft Contact Lens, Johnson & Johnson Vision Care, Inc. (2008) 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
- K113168: Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal Toric (2012), 12 descendants of its own
- K182902: Precision1 (2018), 4 descendants of its own
- K180398: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal (2018), 4 descendants of its own
- K230785: Precision1, Precision1 for Astigmatism (2023), 3 descendants of its own
- K233856: Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (2023), 2 descendants of its own

## Indications for use
The VISTAKON®(narafilcon B) 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 1.00D or less of astigmatism. The VISTAKON® (narafilcon B) 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 4.00D of ADD power or less and 0.75D of astigmatism or less. The VISTAKON® (narafilcon B) 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 B) 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 4.00D of ADD power or less and 10.00D of astigmatism or less. VISTAKON® (narafilcon B) 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 disinfection is required.

Source page: https://510kreport.com/device/K100349
Methodology: https://510kreport.com/methodology