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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 K240816
Device Name MeDioStar
Applicant
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena,  DE 07745
Applicant Contact Tom Gruender
Correspondent
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena,  DE 07745
Correspondent Contact Tom Gruender
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/25/2024
Decision Date 04/23/2024
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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