Zeltiq Aesthetics Inc
Pleasanton, CA, US
ZELTIQ AESTHETICS, INC. appears in FDA device records in Pleasanton, CA. FDA records list 17 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Zeltiq Aesthetics Inc between 2008 and 2024. The busiest year on record is 2015, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233804 | Resonic Rapid Acoustic Pulse Device | GEX | Substantially Equivalent | |
| K222629 | Resonic Rapid Acoustic Pulse Device | GEX | Substantially Equivalent | |
| K212707 | CoolSculpting Elite System | OOK | Substantially Equivalent | |
| K193566 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | |
| K183514 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | |
| K181740 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | |
| K172144 | CoolSculpting System | OOK | Substantially Equivalent | |
| K171069 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | |
| K162050 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | |
| K160259 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | |
| K151179 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | |
| K142491 | ZEL TIQ CoolSculpting System | OOK | Substantially Equivalent | |
| K133212 | ZELTIQ COOLSCULPTING SYSTEM | OOK | Substantially Equivalent | |
| K120023 | ZELTIQ COOLSCULPTING | OOK | Substantially Equivalent | |
| DEN090002 | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | OOK | Unknown | |
| K090094 | ZELTIQ SYSTEM | GEX | Substantially Equivalent | |
| K080118 | ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009974688 | 3009974688 | ZELTIQ AESTHETICS INC. | 5996 Gleason Drive, Dublin, CA 94568 US | 2026 | |
| 3007215625 | 3007215625 | ZELTIQ AESTHETICS, INC. | 4410 Rosewood Dr, Pleasanton, CA 94588 US | 2026 | |
| 3011837770 | 3011837770 | ZELTIQ AESTHETICS, INC. | 7041 Las Positas Road, Livermore, CA 94551 US | 2026 | |
| 3014214244 | 3014214244 | Zeltiq Aesthetics Inc | 6723 Sierra Ct., Dublin, CA 94568 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1350-2022 | CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe. | Class II | Open, Classified | |
| Z-1349-2022 | CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000 | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe. | Class II | Open, Classified | |
| Z-1348-2022 | CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000 | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe. | Class II | Open, Classified | |
| Z-1347-2022 | CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe. | Class II | Open, Classified | |
| Z-1346-2022 | CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe. | Class II | Open, Classified | |
| Z-2383-2021 | CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2 | An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain