FDA 510(k) Application Details - K233732

Device Classification Name	More FDA Info for this Device
510(K) Number	K233732
Device Name	CoolSculpting Elite System
Applicant	ZELTIQ Aesthetics, Inc. (acquired by Allergan Aesthetics and now, an AbbVie, Inc. company) 4410 Rosewood Drive Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Victoria Montemayor 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	11/21/2023
Decision Date	09/12/2024
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