Device Classification Name |
focused ultrasound for tissue heat or mechanical cellular disruption
|
De Novo Number |
DEN080006 |
510(K) Number |
K072505
|
Device Name |
ULTHERA SYSTEM, MODEL 8850-0001 |
Requester |
ulthera, inc. |
33 south sycamore street |
mesa,
AZ
85202
|
|
Contact |
randall e miller |
|
Regulation Number | 878.4590
|
Classification Product Code |
|
Date Received | 04/11/2008 |
Decision Date | 09/11/2009 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Classification Order |
Classification Order
|
Type |
Post-NSE
|
|
|