Cleared Traditional

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

K181920 · CooperVision, Inc. · Ophthalmic
Dec 2018
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K181920 is an FDA 510(k) clearance for the Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 11, 2018, 146 days after receiving the submission on July 18, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K181920 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2018
Decision Date December 11, 2018
Days to Decision 146 days
Submission Type Traditional
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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