Cleared Special

PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC

K111966 · CooperVision, Inc. · Ophthalmic
Sep 2011
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K111966 is an FDA 510(k) clearance for the PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC, 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 September 15, 2011, 66 days after receiving the submission on July 11, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K111966 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2011
Decision Date September 15, 2011
Days to Decision 66 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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