Device Classification Name |
powered microneedle device
|
De Novo Number |
DEN160029 |
Device Name |
SkinPen Precision System |
Requester |
BELLUS MEDICAL, LLC. |
12001 n. central expwy. |
dallas,
TX
75243
|
|
Contact |
jennifer block |
|
Regulation Number | 878.4430
|
Classification Product Code |
|
Date Received | 07/05/2016 |
Decision Date | 03/01/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|