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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K020527
Device Name HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
Applicant
American Optisurgical, Inc.
25501 Arctic Ocean
Lake Forest,  CA  92630
Applicant Contact NANETTE CANEPA
Correspondent
American Optisurgical, Inc.
25501 Arctic Ocean
Lake Forest,  CA  92630
Correspondent Contact NANETTE CANEPA
Regulation Number886.4670
Classification Product Code
HQC  
Date Received02/19/2002
Decision Date 07/09/2002
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
Recalls CDRH Recalls
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