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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 K080803
Device Name VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
Applicant
American Optisurgical, Inc.
25501 Arctic Ocean
Lake Forest,  CA  92630
Applicant Contact DAVID SALZBERG
Correspondent
American Optisurgical, Inc.
25501 Arctic Ocean
Lake Forest,  CA  92630
Correspondent Contact DAVID SALZBERG
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
NKX  
Date Received03/21/2008
Decision Date 09/22/2008
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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