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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 K212790
Device Name XLase Plus
Applicant
Biotec Italia, Srl
Viale Della Repubblica 20, 36031
Dueville (Vi),  IT
Applicant Contact Edoardo Milanello
Correspondent
Evoskin, LLC
6 Lincoln Knolll Ln Suite 100a
Burlington,  MA  01803
Correspondent Contact Mike Berisha
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONF  
Date Received09/01/2021
Decision Date 08/15/2022
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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