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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K862987
Device Name MODEL 1000 OPHTHALMIC LASER SYSTEM
Applicant
COOPERVISION, INC.
LASER DIVISION
3420 CENTRAL EXPRESSWAY
SANTA CLARA,  CA  95051
Applicant Contact CHARLES L ROSE
Correspondent
COOPERVISION, INC.
LASER DIVISION
3420 CENTRAL EXPRESSWAY
SANTA CLARA,  CA  95051
Correspondent Contact CHARLES L ROSE
Regulation Number886.4390
Classification Product Code
HQF  
Date Received08/07/1986
Decision Date 09/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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