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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
Device Name OPTIMEDICA CATALYS PRECISION LASER SYSTEM
Applicant
OPTIMEDICA CORPORATION
3100 CORONADO DRIVE
SANTA CLARA,  CA  95054
Applicant Contact ALAN MARQUARDT
Correspondent
Johnson & Johnson Surgical Vision, Inc.
31 Technology Drive, Suite 200
Irvine,  CA  92618
Correspondent Contact ALAN MARQUARDT
Regulation Number886.4390
Classification Product Code
OOE  
Date Received11/23/2011
Decision Date 12/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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