FDA 510(k) Application Details - K250418

Device Classification Name	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption   More FDA Info for this Device
510(K) Number	K250418
Device Name	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant	Ulthera Inc. 6501 Six Forks Road Raleigh, NC 27615 US Other 510(k) Applications for this Company
Contact	Christopher Lefancheck Other 510(k) Applications for this Contact
Regulation Number	878.4590   More FDA Info for this Regulation Number
Classification Product Code	OHV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2025
Decision Date	05/13/2025
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