# K234127: Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker

- Pathway: 510(k) (Special)
- Applicant: CooperVision, Inc.
- Decided: Jan 25, 2024 after 28 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: 7 generations back to P810005 (1981). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181920: Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker, CooperVision, Inc. (2018) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K234127
Methodology: https://510kreport.com/methodology