# K133740: Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti Multifocal with Tint

- Pathway: 510(k) (Traditional)
- Applicant: Sauflon Pharmaceuticals, Ltd.
- Decided: Mar 5, 2014 after 86 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130342: Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker, Sauflon Pharmaceuticals, Ltd. (2013) Summary page 4.
- K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs, Ciba Vision Corporation (2004) Summary page 2.
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses, Ciba Vision Corporation (2008) Summary page 2.

## Indications for use
The SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The SAUFLON CLARITI TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear 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 MULTIFOCAL (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint 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 that may require a reading addition of +4.00 Diopters or less. The SAUFLON CLARITI MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint 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 that may exhibit astigmatism up to 10.00 Diopters and that may require a reading addition of +4.00 Diopters or less. The lenses may be prescribed for daily wear for up to one month with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion as recommended by the eye care professional. Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact lens with UV blocker and handling tint helps protect against transmission of harmful UV radiation to the cornea and into the eye. The lens has a tint added to make the lens more visible for handling.

Source page: https://510kreport.com/device/K133740
Methodology: https://510kreport.com/methodology