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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 K030508
Device Name DEPILASE TRIO LASE LASER SYSTEM
Applicant
Depilase Group , Ltd.
One Canada Square
Canary Wharf
London,  GB E14 5DY
Applicant Contact MARIO LUCA RUSSO
Correspondent
Depilase Group , Ltd.
One Canada Square
Canary Wharf
London,  GB E14 5DY
Correspondent Contact MARIO LUCA RUSSO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/19/2003
Decision Date 05/20/2003
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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