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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
po box 17190
anaheim,  CA  92817 7190
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 (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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