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


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 road
suite 370
pleasanton, 
CA 
94588

Applicant Contact lisa hahn
Correspondent
COOPERVISION, INC.
6150 stoneridge mall road
suite 370
pleasanton, 
CA 
94588

Correspodent Contact lisa hahn
Regulation Number 886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received 07/11/2011
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