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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Microneedle Device
510(k) Number K252591
Device Name Automatic Micro Needle System (CODE-X)
Applicant
Woorhi Mechatronics Co., Ltd.
58, Sanbon-Ro, 48beon-Gil
Gunpo-Si,  KR 15846
Applicant Contact Jungsu Lee
Correspondent
Woorhi Mechatronics Co., Ltd.
58, Sanbon-Ro, 48beon-Gil
Gunpo-Si,  KR 15846
Correspondent Contact Jungsu Lee
Regulation Number878.4430
Classification Product Code
QAI  
Date Received08/15/2025
Decision Date 05/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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