Cleared Special

Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)

K202756 · CooperVision, Inc. · Ophthalmic
Oct 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K202756 is an FDA 510(k) clearance for the Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A), a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (San Ramon, US). The FDA issued a Cleared decision on October 20, 2020, 29 days after receiving the submission on September 21, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K202756 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2020
Decision Date October 20, 2020
Days to Decision 29 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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