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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 K113479
Model CATALYS SYSTEM
Device Name OPTIMEDICA CATALYS PRECISION LASER SYSTEM
Original Applicant
OPTIMEDICA CORPORATION
3100 coronado drive
santa clara,  CA  95054
Original Contact alan marquardt
Regulation Number886.4390
Classification Product Code
OOE  
Date Received11/23/2011
Decision Date 12/21/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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