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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 K172363
Device Name DEKA SMARTXIDE ULTRASPEED
Applicant
El.En Electronic Engineering Spa
Via Baldanzese, 17
Calenzano,  IT 50041
Applicant Contact Paolo Peruzzi
Correspondent
El.En Electronic Engineering Spa
Via Baldanzese, 17
Calenzano,  IT 50041
Correspondent Contact Paolo Peruzzi
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/04/2017
Decision Date 11/17/2017
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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