FDA 510(k) Application Details - K221070

Device Classification Name	More FDA Info for this Device
510(K) Number	K221070
Device Name	DP4 Microneedling device
Applicant	Equipmed USA LLC Suite 1100, 4695 Macarthur Court Newport Beach, CA 92660 US Other 510(k) Applications for this Company
Contact	Shaun Kerrigan 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	04/12/2022
Decision Date	12/20/2022
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