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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 K093162
Device Name FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID
Applicant
Fotona D.D.
Stegne 7
Ljubljana,  SI 1210
Applicant Contact STOJAN TROST
Correspondent
Fotona D.D.
Stegne 7
Ljubljana,  SI 1210
Correspondent Contact STOJAN TROST
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/06/2009
Decision Date 01/22/2010
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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