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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Disruption Of Adipocyte Cells For Aesthetic Use
510(k) Number K231971
Device Name DEKA PHYSIQ 360
Applicant
El.En S.P.A.
Via Baldanzese 17
Calenzano,  IT 50141
Applicant Contact Paolo Peruzzi
Correspondent
El.En S.P.A.
Via Baldanzese 17
Calenzano,  IT 50141
Correspondent Contact Paolo Peruzzi
Regulation Number878.5400
Classification Product Code
PKT  
Date Received07/03/2023
Decision Date 09/26/2023
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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