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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 K213889
Device Name PicoStar
Applicant
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena,  DE 07747
Applicant Contact Carolin Kuehling
Correspondent
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena,  DE 07747
Correspondent Contact Carolin Kuehling
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/13/2021
Decision Date 04/22/2022
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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