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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Femtosecond Laser
510(k) Number K122386
Device Name VICTUS FEMTOSECOND LASER PLATFORM
Applicant
Technolas Perfect Vision GmbH
P.O. Box 17190
Anaheim Hills,  CA  92817
Applicant Contact BETTY M JOHNSON
Correspondent
Technolas Perfect Vision GmbH
P.O. Box 17190
Anaheim Hills,  CA  92817
Correspondent Contact BETTY M JOHNSON
Regulation Number886.4390
Classification Product Code
OOE  
Subsequent Product Code
HQF  
Date Received08/06/2012
Decision Date 02/08/2013
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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