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510(k) K243143

E-PEN (E-PEN) by Bomtech Electronics Co., Ltd. — Product Code QAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2025
Date Received
September 30, 2024
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 Bomtech Electronics Co., Ltd.

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