# K130342: Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker

- Pathway: 510(k) (Traditional)
- Applicant: Sauflon Pharmaceuticals, Ltd.
- Decided: Aug 5, 2013 after 175 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: 5 generations back to P810005 (1981). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 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.
- 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.

## Most influential descendants
- K251573: VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (2025), 0 descendants of its own
- K133740: Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti Multifocal with Tint (2014), 0 descendants of its own

## Indications for use
The SAUFLON (LARITI tsomohilcoi A) Soft (hydrophilic) Contact Lens with UJV blocker is indicated for nontlil) disposable wvear for the correction ol refractive ametropia (myopia andhpropia) in phakiu or aphakic persons with non-diseased eyes that may exhibit astigmatism up to02.00 Diopters that does not interti~re with visual acuity. thie SAUrFLN CIARITI TORIC (somonflcoit A) Soft (hydrrophilic) Contact Lents with t I blocker is indicated for monthly disposable wear tinr the optical correction of refmnctivec mopandhperopla) ini phallic tor aphakic persons with non-diseased eyes that way exhibit astigmatism up to 10.00 Diopters. The SAUFLON CLARITI MUILTIFOCAL isontofilcon A) Sill (h~drophilic) Contact Lens with I'V blocker is indicated lbr monthly. disposable vwear lIm the optical correction or refraie ametropia (myopia and hy-pemopia) and/ort presbyopia in phnkie or aphakic persons with nion-dieased eyes that may require a reading addition of +3.00 Diopters or less and tna exhibit astigmiatism up to 1.50 Diopters or less. The SAUFLU)N CLARITI MULTIFOCAL TORIC (somotilcon A) Soil thydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive anietropia (myopia and hyperopiaj and/or preshyopia in phakie or aphakic pertsons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters tnd tiat may%require a reading addition of +3.00 Dioptiers or less. I he lense, ma> he prescribed for daily wear s'ithi removal (or cleanting und disinfectiotn (chemical. not heat) prior to reinsenion as recommended b%lte eye care professional. Sauflon Clariti (sornotilcon A) Soil (hydrophilic) Contact tens with UV blocker help protect against Irdnsmission of harmful 0IV radiation itoIhe ct'Tnca atd into the eye.

Source page: https://510kreport.com/device/K130342
Methodology: https://510kreport.com/methodology