Cleared Special

PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR

K081865 · CooperVision, Inc. · Ophthalmic
Sep 2008
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K081865 is an FDA 510(k) clearance for the PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (Scottsville,, US). The FDA issued a Cleared decision on September 29, 2008, 90 days after receiving the submission on July 1, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K081865 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2008
Decision Date September 29, 2008
Days to Decision 90 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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