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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 K112669
Device Name TATTOOSTAR EFFECT Y
Applicant
ASCLEPION LASER TECHNOLOGIES GMBH
BRUESSELER STR. 10
JENA,  DE 07747
Applicant Contact ANTJE KATZER
Correspondent
ASCLEPION LASER TECHNOLOGIES GMBH
BRUESSELER STR. 10
JENA,  DE 07747
Correspondent Contact ANTJE KATZER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/14/2011
Decision Date 05/11/2012
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
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