Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)— 510(k) K202756

Clearance details

Applicant

CooperVision, Inc.

Product code

Code LPL

Device class

Class 2

Regulation

21 CFR 886.5925

Advisory panel

Ophthalmic

Date received

2020-09-21

Decision date

2020-10-20

Decision

Substantially Equivalent

Clearance type

Special

Location

San Ramon, CA, US

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• K234127 — Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker2024-01-25
• K220070 — MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens2022-02-04
• K213164 — Avaira Vitality2021-10-26
• K191763 — MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC2020-03-23
• K190965 — MyDay2019-04-29

Injury

988

Other

4

Total

992

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →