Zeltiq Aesthetics, Inc
FDA Regulatory Profile
Zeltiq Aesthetics, Inc appears in FDA public data with 6 recalls, 17 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1349-2022, Class II) was initiated on June 9, 2022. Its most recent 510(k) clearance was granted on February 1, 2024.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 17
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1349-2022 | Class II | CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000 | June 9, 2022 |
| Z-1350-2022 | Class II | CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 | June 9, 2022 |
| Z-1346-2022 | Class II | CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 | June 9, 2022 |
| Z-1347-2022 | Class II | CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 | June 9, 2022 |
| Z-1348-2022 | Class II | CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000 | June 9, 2022 |
| Z-2383-2021 | Class II | CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1 | July 5, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233804 | Resonic Rapid Acoustic Pulse Device | February 1, 2024 |
| K222629 | Resonic Rapid Acoustic Pulse Device | September 25, 2022 |
| K212707 | CoolSculpting Elite System | November 5, 2021 |
| K193566 | ZELTIQ CoolSculpting System | January 21, 2020 |
| K183514 | ZELTIQ CoolSculpting System | January 14, 2019 |
| K181740 | ZELTIQ CoolSculpting System | August 29, 2018 |
| K172144 | CoolSculpting System | November 1, 2017 |
| K171069 | ZELTIQ CoolSculpting System | July 7, 2017 |
| K162050 | ZELTIQ CoolSculpting System | November 21, 2016 |
| K160259 | ZELTIQ CoolSculpting System | March 23, 2016 |
| K151179 | ZELTIQ CoolSculpting System | September 22, 2015 |
| K142491 | ZEL TIQ CoolSculpting System | January 26, 2015 |
| K133212 | ZELTIQ COOLSCULPTING SYSTEM | April 9, 2014 |
| K120023 | ZELTIQ COOLSCULPTING | May 2, 2012 |
| DEN090002 | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | August 24, 2010 |
| K090094 | ZELTIQ SYSTEM | May 20, 2009 |
| K080118 | ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE | May 2, 2008 |