FDA 510(k) Application Details - K181740

Device Classification Name	More FDA Info for this Device
510(K) Number	K181740
Device Name	ZELTIQ CoolSculpting System
Applicant	ZELTIQ Aesthetics, Inc. 4410 Rosewood Drive Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Ewald Riechert Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OOK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2018
Decision Date	08/29/2018
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