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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 K023041
Device Name W.O.M. LASER U100
Applicant
W.O.M. World of Medicine AG
91 Trowbridge St.
Cambridge,  MA  02138
Applicant Contact SUSANNE RAAB
Correspondent
W.O.M. World of Medicine AG
91 Trowbridge St.
Cambridge,  MA  02138
Correspondent Contact SUSANNE RAAB
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/12/2002
Decision Date 12/11/2002
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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