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510(k) K182407

Exceed Microneedling device by Mt. Derm GmbH — Product Code QAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2019
Date Received
September 4, 2018
Clearance Type
Traditional
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.

Other clearances by Mt. Derm GmbH

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