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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 K081619
Device Name CHROMOLITE EP
Applicant
Chromogenex Technologies Limited
Units 1& 2 Heol Rhosyn
Parc Dafen
Llanelli, Carmarthenshire,  GB SA14 8QG
Applicant Contact PETER R BEVAN
Correspondent
Chromogenex Technologies Limited
Units 1& 2 Heol Rhosyn
Parc Dafen
Llanelli, Carmarthenshire,  GB SA14 8QG
Correspondent Contact PETER R BEVAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/09/2008
Decision Date 07/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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