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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 K110099
Device Name PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT
Applicant
CooperVision, Inc.
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton,  CA  94588
Applicant Contact SARAH HARRINGTON
Correspondent
CooperVision, Inc.
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton,  CA  94588
Correspondent Contact SARAH HARRINGTON
Regulation Number886.5925
Classification Product Code
LPL  
Date Received01/13/2011
Decision Date 06/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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