# K180299: ACUVUE OASYS (senofilcon A) with Photochromic Additive

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Vision Care, Inc.
- Decided: Apr 10, 2018 after 67 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 K042275 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042275: Vistakon (Senofilcon a) Soft Contact Lens, Vistakon (2004) Summary page 5.

## Indications for use
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive (spherical) is indicated for daily wear 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 ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 10.00D or less of astigmatism. The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may have 0.75D or less of astigmatism. The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism. These lenses are also indicated for the attenuation of bright light as they contain a photochromic additive which dynamically absorbs visible light. These lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye. Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2-weeks (14 days).

Source page: https://510kreport.com/device/K180299
Methodology: https://510kreport.com/methodology