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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 K020412
Device Name DEPILASE TWIN LASE LASER SYSTEM
Applicant
Depilase Group , Ltd.
One Canada Sq.
London,  GB E14 5DY
Applicant Contact MARIO RUSSO
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/07/2002
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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