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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 K150323
Device Name FEMTO LDV Z8 Surgical Laser
SIE AG,Surgical Instrument Engineering
Allmendstrasse 11
Port,  CH CH2562
Applicant Contact Frank Ziemer
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number886.4390
Classification Product Code
Date Received02/09/2015
Decision Date 10/23/2015
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