Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AbbVieLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record. See the AbbVie group view.
As of Nov 15, 2026, FDA's public records list Zeltiq Aesthetics, Inc. with 16 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Feb 1, 2024: Resonic Rapid Acoustic Pulse Device.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 1, 2024 | Resonic Rapid Acoustic Pulse DeviceK233804 · GEX | 510(k) clearances |
| Sep 25, 2022 | Resonic Rapid Acoustic Pulse DeviceK222629 · GEX | 510(k) clearances |
| Jun 9, 2022 | CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000Class II · Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for ad | Device recalls |
| Jun 9, 2022 | CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000Class II · Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for ad | Device recalls |
| Jun 9, 2022 | CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000Class II · Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for ad | Device recalls |
| Jun 9, 2022 | CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000Class II · Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for ad | Device recalls |
| Jun 9, 2022 | CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000Class II · Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for ad | Device recalls |
| Nov 5, 2021 | CoolSculpting Elite SystemK212707 · OOK | 510(k) clearances |
| Jul 5, 2021 | CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2Class II · An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to | Device recalls |
| Jan 21, 2020 | ZELTIQ CoolSculpting SystemK193566 · OOK | 510(k) clearances |
| Jan 14, 2019 | ZELTIQ CoolSculpting SystemK183514 · OOK | 510(k) clearances |
| Aug 29, 2018 | ZELTIQ CoolSculpting SystemK181740 · OOK | 510(k) clearances |
| Nov 1, 2017 | CoolSculpting SystemK172144 · OOK | 510(k) clearances |
| Jul 7, 2017 | ZELTIQ CoolSculpting SystemK171069 · OOK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
