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Zeltiq Aesthetics, Inc

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
17
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1349-2022Class IICoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000June 9, 2022
Z-1348-2022Class IICoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000June 9, 2022
Z-1350-2022Class IICoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000June 9, 2022
Z-1346-2022Class IICoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000June 9, 2022
Z-1347-2022Class IICoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000June 9, 2022
Z-2383-2021Class IICoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1July 5, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K233804Resonic Rapid Acoustic Pulse DeviceFebruary 1, 2024
K222629Resonic Rapid Acoustic Pulse DeviceSeptember 25, 2022
K212707CoolSculpting Elite SystemNovember 5, 2021
K193566ZELTIQ CoolSculpting SystemJanuary 21, 2020
K183514ZELTIQ CoolSculpting SystemJanuary 14, 2019
K181740ZELTIQ CoolSculpting SystemAugust 29, 2018
K172144CoolSculpting SystemNovember 1, 2017
K171069ZELTIQ CoolSculpting SystemJuly 7, 2017
K162050ZELTIQ CoolSculpting SystemNovember 21, 2016
K160259ZELTIQ CoolSculpting SystemMarch 23, 2016
K151179ZELTIQ CoolSculpting SystemSeptember 22, 2015
K142491ZEL TIQ CoolSculpting SystemJanuary 26, 2015
K133212ZELTIQ COOLSCULPTING SYSTEMApril 9, 2014
K120023ZELTIQ COOLSCULPTINGMay 2, 2012
DEN090002ZELTIQ AESTHETICS DERMAL COOLING DEVICEAugust 24, 2010
K090094ZELTIQ SYSTEMMay 20, 2009
K080118ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICEMay 2, 2008