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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 K141079
Device Name OPTIMEDICA CATALYS PRECISION LASER SYSTEM
Applicant
OPTIMEDICA CORPORATION
1310 MOFFETT PARK DRIVE
SUNNYVALE,  CA  94089
Applicant Contact STEVE JWANOUSKOS
Correspondent
Johnson & Johnson Surgical Vision, Inc.
31 Technology Drive, Suite 200
Irvine,  CA  92618
Correspondent Contact STEVE JWANOUSKOS
Regulation Number886.4390
Classification Product Code
OOE  
Date Received04/25/2014
Decision Date 09/11/2014
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
Recalls CDRH Recalls
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