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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 K143723
Device Name SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
Applicant
Fotona D.D.
Stegne 7
Ljubljana,  SI 1000
Applicant Contact STOJAN TROST
Correspondent
Fotona D.D.
Stegne 7
Ljubljana,  SI 1000
Correspondent Contact STOJAN TROST
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received12/29/2014
Decision Date 04/09/2015
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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