Cleared Special

AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS

K133627 · CooperVision, Inc. · Ophthalmic
Dec 2013
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K133627 is an FDA 510(k) clearance for the AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT 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 December 23, 2013, 27 days after receiving the submission on November 26, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K133627 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2013
Decision Date December 23, 2013
Days to Decision 27 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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