Cleared Traditional

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal

K181454 · Alcon Laboratories, Inc. · Ophthalmic
Nov 2018
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K181454 is an FDA 510(k) clearance for the DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on November 21, 2018, 170 days after receiving the submission on June 4, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K181454 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2018
Decision Date November 21, 2018
Days to Decision 170 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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