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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 K053604
Device Name WAVELIGHT IDAS
Applicant
Wavelight Laser Technologie AG
Frankfurter Strasse 229
Neu-Isenburg, Hessen,  DE 63263
Applicant Contact THORSTEN CRETER
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFFREY D RONGERO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/27/2005
Decision Date 02/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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