Cleared Special

AIR OPTIX COLORS

K222500 · Alcon Laboratories, Inc. · Ophthalmic
Sep 2022
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K222500 is an FDA 510(k) clearance for the AIR OPTIX COLORS, 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 September 15, 2022, 28 days after receiving the submission on August 18, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K222500 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2022
Decision Date September 15, 2022
Days to Decision 28 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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