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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fat Reducing Low Level Laser
510(k) Number K111501
Device Name I-LIPO SYSTEM
Applicant
Chromogenex Technologies Limited
Units 1& 2 Heol Rhosyn
Parc Dafen Industrial Estate
Llanelli, Carmarthenshire,  GB SA14 8QG
Applicant Contact PETER R BEVAN
Correspondent
Chromogenex Technologies Limited
Units 1& 2 Heol Rhosyn
Parc Dafen Industrial Estate
Llanelli, Carmarthenshire,  GB SA14 8QG
Correspondent Contact PETER R BEVAN
Regulation Number878.5400
Classification Product Code
OLI  
Date Received05/31/2011
Decision Date 03/23/2012
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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