Data / Medical devices / United States / Zeltiq Aesthetics, Inc.
Zeltiq Aesthetics, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 13 510(k) clearances
Zeltiq Aesthetics, Inc. is registered with the FDA (registration 3007215625) in Pleasanton, CA, United States. It lists 2 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 12, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007215625
- Address
- 4410 Rosewood Dr, Pleasanton, CA, United States, 94588
- Owner or operator
- ZELTIQ Aesthetics, Inc. (10025698)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 17, 2010
- Registered through
- 2026
- Brand names listed
- CoolSculpting Elite System, CoolSculpting System, DPRO, EnDoucer Dermolissage, SP3, Silk Peel Dermalinfusion, SilkPeel MD, SilkPeel Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Specification developer | accessdata.fda.gov |
| Dermal Cooling Pack/Vacuum/Massager | OOK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 12, 2024 | K233732 | CoolSculpting Elite System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | accessdata.fda.gov |
| November 5, 2021 | K212707 | CoolSculpting Elite System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| January 21, 2020 | K193566 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| January 14, 2019 | K183514 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| August 29, 2018 | K181740 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| July 7, 2017 | K171069 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| November 21, 2016 | K162050 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| March 23, 2016 | K160259 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| September 22, 2015 | K151179 | ZELTIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| January 26, 2015 | K142491 | ZEL TIQ CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| April 9, 2014 | K133212 | ZELTIQ COOLSCULPTING SYSTEM | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| May 2, 2012 | K120023 | ZELTIQ COOLSCULPTING | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. | accessdata.fda.gov |
| August 24, 2010 | DEN090002 | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | OOK | Unknown | Zeltiq Aesthetics | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 9, 2022 | 90331 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 5, 2021 | 88397 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
Updated September 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.