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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 K253100
Device Name MultiPulse TFL
Applicant
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena,  DE 07745
Applicant Contact Francesco Dell'Antonio
Correspondent
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena,  DE 07745
Correspondent Contact Francesco Dell'Antonio
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/24/2025
Decision Date 10/23/2025
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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