Cleared Special

AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL

K113245 · CooperVision, Inc. · Ophthalmic
Dec 2011
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K113245 is an FDA 510(k) clearance for the AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL, 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 December 2, 2011, 30 days after receiving the submission on November 2, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K113245 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2011
Decision Date December 02, 2011
Days to Decision 30 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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