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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 K053324
Device Name CHROMOLITE SYSTEM
Applicant
Chromogenex Plc
Units 1& 2 Heol Rhosyn
Parc Dafen
Llanelli, Carmarthenshire,  GB SA14 8QG
Applicant Contact CHRIS WILLIAMS
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/01/2005
Decision Date 01/05/2006
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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