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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
Applicant
Optimedica Corporation
1310 Moffett Park Dr.
Sunnyvale,  CA  94089
Applicant Contact ALAN MARQUARDT
Correspondent
Johnson & Johnson Surgical Vision, Inc.
31 Technology Dr. Suite 200
Irvine,  CA  92618
Correspondent 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 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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