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510(k) K230420

Dr. pen Microneedling System by Guangzhou Ekai Electronic Technology Co., Ltd. — Product Code QAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2023
Date Received
February 16, 2023
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.

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