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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 K011175
Device Name W.O.M. LASER U100
Applicant
W.O.M. World of Medicine GmbH
91 Trowbridge St.
# 21
Cambridge,  MA  02138
Applicant Contact MICHAEL MCGRAIL
Correspondent
W.O.M. World of Medicine GmbH
91 Trowbridge St.
# 21
Cambridge,  MA  02138
Correspondent Contact MICHAEL MCGRAIL
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
FFK  
Date Received04/17/2001
Decision Date 11/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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