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


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 road
suite 370
pleasanton, 
CA 
94588

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

Correspodent Contact sarah harrington
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 01/13/2011
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