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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
Device Name CATALYS PRECISION LASER SYSTEM
Original Applicant
OPTIMEDICA CORPORATION
1310 moffett park drive
sunnyvale,  CA  94089
Original Contact alan marquardt
Regulation Number886.4390
Classification Product Code
OOE  
Date Received04/10/2012
Decision Date 08/28/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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