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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Ac-Powered
510(k) Number K912740
Device Name ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)
Applicant
Visionary Systems, Inc.
1810 N. Norton Ave.
Tucson,  AZ  85719
Applicant Contact STEVEN R LANGE
Correspondent
Visionary Systems, Inc.
1810 N. Norton Ave.
Tucson,  AZ  85719
Correspondent Contact STEVEN R LANGE
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received06/21/1991
Decision Date 12/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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