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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 K192483
Device Name MeDioStar
Applicant
Asclepion Laser Technologies GmbH
Busseler St. 10
Jena,  DE 07747
Applicant Contact Antje Katzer
Correspondent
Asclepion Laser Technologies GmbH
Busseler St. 10
Jena,  DE 07747
Correspondent Contact Dania Di Pietro Paolo
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/10/2019
Decision Date 03/13/2020
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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