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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 K111475
Device Name AURIGA XL
Applicant
STARMEDTEC GMBH
KREUZSTRASSE 22
STARNBERG,  DE 82319
Applicant Contact GREGOR WEIDEMANN
Correspondent
STARMEDTEC GMBH
KREUZSTRASSE 22
STARNBERG,  DE 82319
Correspondent Contact GREGOR WEIDEMANN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/27/2011
Decision Date 09/28/2011
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
Recalls CDRH Recalls
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