Cleared Special

DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal

K202448 · Alcon Laboratories, Inc. · Ophthalmic
Sep 2020
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K202448 is an FDA 510(k) clearance for the DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal, a Lens, Contact, (disposable) (Class II — Special Controls, product code MVN), submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on September 22, 2020, 27 days after receiving the submission on August 26, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K202448 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2020
Decision Date September 22, 2020
Days to Decision 27 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MVN — Lens, Contact, (disposable)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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