I-LIPO SYSTEM


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

Correspodent Contact peter r bevan
Regulation Number 878.5400
Classification Product Code
OLI  
Date Received 05/31/2011
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