FDA 510(k) Application Details - K230420

Device Classification Name	More FDA Info for this 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 510000 CN Other 510(k) Applications for this Company
Contact	Guihua Chen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2023
Decision Date	08/11/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review