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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 K121091
Model CATALYS SYSTEM
Device Name CATALYS PRECISION LASER SYSTEM
Applicant
OPTIMEDICA CORPORATION
1310 moffett park drive
sunnyvale,  CA  94089
Contact alan marquardt
Regulation Number886.4390
Classification Product Code
OOE  
Date Received04/10/2012
Decision Date 08/28/2012
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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