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510(k) DEN160029

SkinPen Precision System by Bellus Medical, LLC — Product Code QAI

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 1, 2018
Date Received
July 5, 2016
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Microneedle Device
Device Class
Class II
Regulation Number
878.4430
Review Panel
SU
Submission Type

A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.

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