Cleared Traditional

DAILIES TOTAL1?; DAILIES TOTAL1? Multifocal

K254052 · Alcon Laboratories, Inc. · Ophthalmic
Feb 2026
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K254052 is an FDA 510(k) clearance for the DAILIES TOTAL1?; DAILIES TOTAL1? 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 February 13, 2026, 58 days after receiving the submission on December 17, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K254052 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2025
Decision Date February 13, 2026
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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