Cleared Traditional

DAILIES TOTAL1?; DAILIES TOTAL1? Toric; DAILIES TOTAL1? Multifocal; DAILIES TOTAL1? Multifocal Toric

K232921 · Alcon Laboratories, Inc. · Ophthalmic
Nov 2023
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K232921 is an FDA 510(k) clearance for the DAILIES TOTAL1?; DAILIES TOTAL1? Toric; DAILIES TOTAL1? Multifocal; DAILIES TOTAL1? Multifocal Toric, 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 16, 2023, 58 days after receiving the submission on September 19, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K232921 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2023
Decision Date November 16, 2023
Days to Decision 58 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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