Cleared Traditional

PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT

K110099 · CooperVision, Inc. · Ophthalmic
Jun 2011
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K110099 is an FDA 510(k) clearance for the PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT, 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 June 29, 2011, 167 days after receiving the submission on January 13, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K110099 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2011
Decision Date June 29, 2011
Days to Decision 167 days
Submission Type Traditional
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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