LIPSONIX(R) SYSTEM MODEL 2


Device Classification Name

focused ultrasound for tissue heat or mechanical cellular disruption

510(k) Number K112626
Device Name LIPSONIX(R) SYSTEM MODEL 2
Applicant
MEDICIS TECHNOLOGIES CORPORATION
11818 north creek parkway n.
bothell, 
WA 
98011

Applicant Contact michael a hoffman
Correspondent
MEDICIS TECHNOLOGIES CORPORATION
11818 north creek parkway n.
bothell, 
WA 
98011

Correspodent Contact michael a hoffman
Regulation Number 878.4590
Classification Product Code
OHV  
Date Received 09/09/2011
Decision Date 10/20/2011
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