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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K130656
Device Name IFUSION
Applicant
Optovue, Inc.
2800 Bayview Dr.
Fremont,  CA  94538
Applicant Contact WILLIAM "BILL" JACKSON
Correspondent
Optovue, Inc.
2800 Bayview Dr.
Fremont,  CA  94538
Correspondent Contact WILLIAM "BILL" JACKSON
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
OBO  
Date Received03/12/2013
Decision Date 07/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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