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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 K090776
Device Name MEGAPULSE LASER SYSTEM AND FIBERS
Applicant
Richard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy.
Vernon Hills,  IL  60061
Applicant Contact RON HASELHORST
Correspondent
Richard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy.
Vernon Hills,  IL  60061
Correspondent Contact RON HASELHORST
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/23/2009
Decision Date 06/02/2009
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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