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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K111966
Device Name PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
Applicant
CooperVision, Inc.
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton,  CA  94588
Applicant Contact LISA HAHN
Correspondent
CooperVision, Inc.
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton,  CA  94588
Correspondent Contact LISA HAHN
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received07/11/2011
Decision Date 09/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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