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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 K231309
Device Name SCAR 3
Applicant
El.En Electroinc Engineering Spa
Via Baldanzese, 17
Calenzano,  IT 50041
Applicant Contact Paolo Peruzzi
Correspondent
El.En Electroinc Engineering Spa
Via Baldanzese, 17
Calenzano,  IT 50041
Correspondent Contact Paolo Peruzzi
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/05/2023
Decision Date 06/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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