Cleared Special

Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric

K243909 · Alcon Laboratories, Inc. · Ophthalmic
Jan 2025
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K243909 is an FDA 510(k) clearance for the Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; 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 January 13, 2025, 25 days after receiving the submission on December 19, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K243909 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2024
Decision Date January 13, 2025
Days to Decision 25 days
Submission Type Special
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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