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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
Original Applicant
TECHNOLAS PERFECT VISION GMBH
po box 17190
anaheim,  CA  92817 7190
Original 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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