# K133472: Sauflon Clariti 1 Day with Tint (Toric/Multifocal)

- Pathway: 510(k) (Traditional)
- Applicant: Souflon Pharmaceuticals, Ltd.
- Decided: Mar 4, 2014 after 112 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: 6 generations back to P810005 (1981). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130331: Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker, Sauflon Pharmaceuticals, Ltd. (2013) Summary page 1.
- K073485: Vistakon (Narafilcon) a Soft Contact Lens, Johnson & Johnson Vision Care, Inc. (2008) Summary page 1.
- K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs, Ciba Vision Corporation (2004) Summary page 1.
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses, Ciba Vision Corporation (2008) Summary page 1.

## Indications for use
The SAUFLON CLARITI I DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blacker and Handling Tint is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hypcropia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmiatisnm up to 2.00 Diopters that does not interfere with visual acuity. The SAUFLO)N CLARITI I DAY TORIC (sontofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint 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 that may exhibit astigmatism up to 10.00 Diopters. The SAUFLON CLARITI I DAY MIULTIFOCAL (somrnoikon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ninetropia (myopia and hyperopia) Mnd/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less. The SAUFLON CLARITI I DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +-4.00 Diopters or less. Sauflon Clariti I Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact lens with UV blocker and Handling Tint help protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K133472
Methodology: https://510kreport.com/methodology