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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 K213559
Device Name FEMTO LDV Z8 Femtosecond Surgical Laser
Applicant
Sie Ag,Surgical Instrument Engineering
Allmendstrasse 11
Port,  CH CH-2502
Applicant Contact Frank Ziemer
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number886.4390
Classification Product Code
OOE  
Date Received11/04/2021
Decision Date 04/21/2022
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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