Cleared Special

AVAIRA (ENFILCON A) CONTACT LENS

K113759 · CooperVision, Inc. · Ophthalmic
Apr 2012
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K113759 is an FDA 510(k) clearance for the AVAIRA (ENFILCON A) CONTACT LENS, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on April 3, 2012, 104 days after receiving the submission on December 21, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K113759 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2011
Decision Date April 03, 2012
Days to Decision 104 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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