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United States·US-MF-000004536
Last updated September 17, 2026
What Zeltiq Aesthetics, Inc. makes
Zeltiq Aesthetics, Inc. makes cryolipolysis body contouring systems, including control units, applicators, applicator liners, gel pads, and program cards, as well as dermabrasion brushes and reusable hot/cold therapy packs.
The company's devices are classified as Class I, Class II, and Class IIb and are listed in the Eudamed, FDA 510(k), and FDA UDI registries; the company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Zeltiq Aesthetics, Inc. make?
Zeltiq Aesthetics, Inc. makes cryolipolysis body contouring systems, including control units, applicators, applicator liners, gel pads, and program cards, as well as dermabrasion brushes and reusable hot/cold therapy packs. These products are designed for non-invasive fat reduction and skin treatment applications. The company's offerings are focused on aesthetic medical devices that use controlled cooling or mechanical exfoliation to achieve clinical outcomes.
Where is Zeltiq Aesthetics, Inc. based?
Zeltiq Aesthetics, Inc. is based in the United States, as indicated in the device data under the COUNTRY field. This location informs the regulatory framework under which the company operates, particularly regarding FDA listings and U.S. market distribution. The U.S. base does not imply federal approval of the company itself, only that its devices may be subject to FDA oversight.
Which registries list Zeltiq Aesthetics, Inc.'s devices?
Zeltiq Aesthetics, Inc.'s devices are listed in the Eudamed (European database), FDA 510(k), and FDA UDI registries. These listings indicate that the devices have been entered into regulatory systems for market surveillance and identification, not that the company or its devices have been approved, cleared, or certified by these agencies. Listing in these registries supports traceability and compliance with medical device regulations in the U.S. and EU.
How are Zeltiq Aesthetics, Inc.'s devices classified?
Zeltiq Aesthetics, Inc.'s devices are classified as Class I, Class II, and Class IIb, reflecting varying levels of regulatory control based on risk. Class I devices are low-risk (e.g., reusable hot/cold therapy packs), Class II devices are moderate-risk (e.g., cryolipolysis applicators and control units), and Class IIb devices are higher-risk (typically used in the EU classification system). Classification determines the regulatory pathway required for market placement, but does not indicate approval of the company or its devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 4410, Rosewood Drive, Pleasanton, California, United States
- Website
- www.coolsculpting.com/
- —
- —
- [email protected]
- Phone
- +1.925.621.7462
- PRRC Contact
- Maria Golovina
- EUDAMED SRN
- US-MF-000004536
- FDA FEI Number
- 3007215625
- DUNS Number
- 809152916
Catalogue (205)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Plexus Handpiece Tubing | A0177 | FDA UDI | Class I | Active |
| CoolAdvantage Core | CS-A3-CAC-XX | FDA UDI | Class II | Active |
| CoolMini Card | BRZ-CD4-02X-003 | FDA UDI | Class II | Active |
| Plexus Diamond Handpiece | A0169 | FDA UDI | Class I | Active |
| CoolSculpting Securement System Straps - Medium | CS-SS-MD-02-00 | FDA UDI | Class II | Active |
| CoolSculpting Elite Control Unit | CS-S3-002-D-00 | FDA UDI | Class II | Active |
| CoolSmooth Card | BRZ-CD1-09X-QCK | FDA UDI | Class II | Active |
| CoolFit | BRZ-AP1-066-000 | FDA UDI | Class II | Active |
| Standard Handpiece O-Rings | A0003 | FDA UDI | Class I | Active |
| CoolCard | BRZ-CD4-06X-024 | FDA UDI | Class II | Active |
| CoolAdvantage Gasket- 8 Pack | BRZ-LN1-160-008 | FDA UDI | Class II | Active |
| CoolLiner Max | BRZ-LN1-08X-008 | FDA UDI | Class II | Active |
| DermalInfusion Pro | A1002 | FDA UDI | Class I | Active |
| CoolMini Card | BRZ-CD1-02X-QCK | FDA UDI | Class II | Active |
| CoolCurve Applicator | BRZ-AP1-062-000 | FDA UDI | Class II | Active |
| BODY Diamond Treatment Tips | B0211 | FDA UDI | Class I | Active |
| Plexus Pore Clarifying Handpiece Kit | A0262 | FDA UDI | Class I | Active |
| Diamond 6 mm Treatment Tip - 80 grit | C1593 | FDA UDI | Class I | Active |
| Pre-Treatment Skin Wipe | CS-CD-PSW-10-00 | FDA UDI | Class II | Active |
| Thigh Applicator | BRZ-AP2-360-000 | FDA UDI | Class II | Active |
| Contour, CoolCurve, CoolAdvantage Petite | BRZ-CN1-140-000 | FDA UDI | Class II | Active |
| CoolSculpting Securement Strap Extra Large | CS-SS-XL-02-00 | FDA UDI | Class II | Active |
| Contour, CoolFit, CoolAdvantage Petite | BRZ-CN2-140-000 | FDA UDI | Class II | Active |
| Contour, CoolFit CoolAdvantage | BRZ-CN3-160-000 | FDA UDI | Class II | Active |
| CoolMini Support Arm System | BRZ-RP2-ARM-001 | FDA UDI | Class II | Active |
| CoolSculpting Elite Card, Direct, USA, CAN 100 Solo TX | CS-C2-D01-1C-00 | FDA UDI | Class II | Active |
| BODY 15mm Treatment Tip - 80 grit | C0294 | FDA UDI | Class I | Active |
| CoolSculpting Elite Applicator Curve 80 (C80) | CS-A3-08C-00 | EUDAMEDFDA UDI | Class IIb | Active |
| CoolSculpting Elite Applicator Flat 165 (F165) | CS-A3-16F-00 | EUDAMEDFDA UDI | Class IIb | Active |
| Zeltiq Coolsculpting System | K133212 | FDA 510(k) | Class II | Active |
| CoolSculpting System | K172144 | FDA 510(k) | Class II | Active |
| ZELTIQ CoolSculpting System | K151179 | FDA 510(k) | Class II | Active |
| Resonic Rapid Acoustic Pulse Device | K222629 | FDA 510(k) | Class II | Active |
| ZELTIQ CoolSculpting System | K193566 | FDA 510(k) | Class II | Active |
| ZELTIQ CoolSculpting System | K160259 | FDA 510(k) | Class II | Active |
| Resonic Rapid Acoustic Pulse Device | K233804 | FDA 510(k) | Class II | Active |
| ZELTIQ CoolSculpting System | K171069 | FDA 510(k) | Class II | Active |
| ZELTIQ CoolSculpting System | K181740 | FDA 510(k) | Class II | Active |
| ZELTIQ CoolSculpting System | K183514 | FDA 510(k) | Class II | Active |
| Zeltiq Aesthetics Dermal Cooling Device | DEN090002 | FDA 510(k) | Class II | Active |
| ZELTIQ CoolSculpting System | K162050 | FDA 510(k) | Class II | Active |
| Zeltiq Aesthetics Cln1 Dermal Cooling Device | K080118 | FDA 510(k) | Class II | Active |
| CoolSculpting Elite System | K212707 | FDA 510(k) | Class II | Active |
| ZEL TIQ CoolSculpting System | K142491 | FDA 510(k) | Class II | Active |
| Zeltiq System | K090094 | FDA 510(k) | Class II | Active |
| CoolSculpting Elite Applicator Flat 125 (F125) | CS-A3-12F-00 | EUDAMEDFDA UDI | Class IIb | Active |
| CoolSculpting Elite Umbilical Cable 2m | CS-A3-UMB-00 | EUDAMEDFDA UDI | Class IIb | Active |
| CoolSculpting Elite Applicator Curve 240 (C240) | CS-A3-24C-00 | EUDAMEDFDA UDI | Class IIb | Active |
| CoolSculpting Elite Applicator Curve 135 (C135) | CS-A3-13C-00 | EUDAMEDFDA UDI | Class IIb | Active |
| CoolSculpting Elite Applicator Curve 150 (C150) | CS-A3-15C-00 | EUDAMEDFDA UDI | Class IIb | Active |
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FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
The FDA recall records for Zeltiq Aesthetics, Inc. consist of 6 records, with the earliest initiated on 2021-07-05 and the most recent on 2022-06-09. The recorded statuses of these recalls are open, classified, and terminated. The reasons given for the recalls include an incorrect error messaging system and a voluntary discontinuation and removal of parallel plate applicators due to an increased complaint rate for adverse events. The recall records provide these details without further explanation or context.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 9, 2022 | Z-1348-2022 | — | open, classified | 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. |
| Jun 9, 2022 | Z-1346-2022 | — | open, classified | 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. |
| Jun 9, 2022 | Z-1349-2022 | — | open, classified | 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. |
| Jun 9, 2022 | Z-1350-2022 | — | open, classified | 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. |
| Jun 9, 2022 | Z-1347-2022 | — | open, classified | 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. |
| Jul 5, 2021 | Z-2383-2021 | — | terminated | 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. |