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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 K231876
Device Name MultiPulse HoPLUS
Applicant
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena,  DE 07747
Applicant Contact Tom Gruender
Correspondent
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena,  DE 07747
Correspondent Contact Tom Gruender
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
GCJ  
Date Received06/26/2023
Decision Date 02/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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