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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 K192539
Device Name Deka Luxea
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  
Subsequent Product Code
ONF  
Date Received09/16/2019
Decision Date 12/16/2019
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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