# K181920: Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Dec 11, 2018 after 146 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 15 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 4.

## Most influential descendants
- K242413: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (2024), 1 descendant of its own
- K251573: VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (2025), 0 descendants of its own
- K234127: Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker (2024), 0 descendants of its own

## Recalls of this device
- Feb 14, 2023 · Class II · Z-1282-2023: The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.

## Indications for use
The CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only 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 CLARITI 1 DAY 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) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters. The CLARITI 1 DAY MULTIFOCAL (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 require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less. The CLARITI 1 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 +3.00 Diopters or less. The Clariti 1 Day (somofilcon A) Soft (hydrophilic) Contact Lenses are indicated 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/K181920
Methodology: https://510kreport.com/methodology