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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K131207
Device Name FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
Applicant
Surgical Instrument Engineering AG
33 Golden Eagle Ln.
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Surgical Instrument Engineering AG
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number886.4390
Classification Product Code
HQF  
Date Received04/29/2013
Decision Date 10/09/2013
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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