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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 K132534
Device Name VICTUS FEMTOSECOND LASER PLATFORM
Applicant
Technolas Perfect Vision GmbH
1025 Sanchez St.
San Francisco,  CA  94114
Applicant Contact KEN NEHMER
Correspondent
Technolas Perfect Vision GmbH
1025 Sanchez St.
San Francisco,  CA  94114
Correspondent Contact KEN NEHMER
Regulation Number886.4390
Classification Product Code
OOE  
Date Received08/13/2013
Decision Date 02/14/2014
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
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