FDA 510(k) Application Details - K241790

Device Classification Name	More FDA Info for this Device
510(K) Number	K241790
Device Name	XCELLARISPRO TWIST microneedling device
Applicant	Dermaroller GmbH Wilhelm-Mast-Strasse 8 Wolfenbuettel 38304 DE Other 510(k) Applications for this Company
Contact	Anna Lena Kaufholz 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	06/21/2024
Decision Date	03/06/2025
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