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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K172819
Device Name LightWalker Laser System Family
Applicant
Fotona D.O.O.
Stegne 7
Ljubljana,  SI
Applicant Contact Marko Berdajs
Correspondent
Fotona D.O.O.
Stegne 7
Ljubljana,  SI
Correspondent Contact Marko Berdajs
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/18/2017
Decision Date 12/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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