FDA.reportPublic FDA data

De Novo DEN160029

Device
SkinPen Precision System
Contact
jennifer block
De Novo number
DEN160029
Product code
QAI
Regulation
878.4430
Classification name
powered microneedle device
Decision
granted (DENG)
Decision date
2018-03-01
Date received
2016-07-05
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
QAI
Device name
Powered Microneedle Device
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4430
Implant
N
Life sustain/support
N