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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 K230420
Device Name Dr. pen Microneedling System
Applicant
Guangzhou Ekai Electronic Technology Co., Ltd.
3/F Building E
No.81 Zijing Road, Liwan District
Guangzhou,  CN 510000
Applicant Contact Guihua Chen
Correspondent
New Risen Enterprise Management Consulting Co., Ltd.
Room 302, Building 3, Hangqian Mansion
Hangqian Street, Lucheng District
Wenzhou,  CN 325000
Correspondent Contact Helen Nan
Regulation Number878.4430
Classification Product Code
QAI  
Date Received02/16/2023
Decision Date 08/11/2023
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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