FDA 510(k) Application Details - K192185

Device Classification Name	More FDA Info for this Device
510(K) Number	K192185
Device Name	The Cellfina System
Applicant	Ulthera, Inc 1840 S. Stapley Dr. Suite 200 Mesa, AZ 85204 US Other 510(k) Applications for this Company
Contact	Lisa Pray Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2019
Decision Date	10/09/2019
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