Cleared Special

FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions

K181796 · Alcon Laboratories, Inc. · Ophthalmic
Aug 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K181796 is an FDA 510(k) clearance for the FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions, 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 August 3, 2018, 29 days after receiving the submission on July 5, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K181796 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2018
Decision Date August 03, 2018
Days to Decision 29 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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