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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 K161455
Device Name Catalys Precision Laser System
Applicant
Optimedica Corporation
1310 Moffet Park Dr.
Sunnyvale,  CA  94089
Applicant Contact Ankur Kaushal
Correspondent
Optimedica Corporation
1310 Moffet Park Dr.
Sunnyvale,  CA  94089
Correspondent Contact Ankur Kaushal
Regulation Number886.4390
Classification Product Code
OOE  
Date Received05/26/2016
Decision Date 09/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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