FDA 510(k) Application Details - K180709

Device Classification Name	More FDA Info for this Device
510(K) Number	K180709
Device Name	truSculpt RF Device; truSculpt; truSculpt 3D
Applicant	Cutera, Inc. 3240 Bayshore Blvd. Brisbane, CA 94005 US Other 510(k) Applications for this Company
Contact	Brad Renton 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	03/19/2018
Decision Date	06/06/2018
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