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510(k) K252591

Automatic Micro Needle System (CODE-X) by Woorhi Mechatronics Co., Ltd. — Product Code QAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2026
Date Received
August 15, 2025
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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