FDA 510(k) Application Details - K122389

Device Classification Name	More FDA Info for this Device
510(K) Number	K122389
Device Name	TRUSCULPT
Applicant	CUTERA, INC. 3240 BAYSHORE BLVD BRISBANE, CA 94005 US Other 510(k) Applications for this Company
Contact	Connie Hoy 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	08/07/2012
Decision Date	11/02/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review