FDA 510(k) Application Details - K243055

Device Classification Name	More FDA Info for this Device
510(K) Number	K243055
Device Name	PrΘime DermaFacial Collagen+
Applicant	EMA Aesthetics, LTD Palmerston House Fenian Street Dublin 2 D02 WD37 IE Other 510(k) Applications for this Company
Contact	Alice Daniels Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	04/15/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review