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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 K060455
Device Name MULTISTAR
Applicant
Asclepion Laser Technologies GmbH
Goeschwitzer Strasse 51-52
Jena,  DE 07745
Applicant Contact REINHARD THIEME
Correspondent
Asclepion Laser Technologies GmbH
Goeschwitzer Strasse 51-52
Jena,  DE 07745
Correspondent Contact REINHARD THIEME
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/22/2006
Decision Date 03/20/2006
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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