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
|
|
Correspondent Contact |
MICHAEL A HOFFMAN |
Regulation Number | 878.4590
|
Classification Product Code |
|
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
|