Data / Medical devices / United States / Zeltiq Aesthetics Inc
Zeltiq Aesthetics Inc: FDA-registered device maker in Dublin, CA, United States, 6 510(k) clearances
Zeltiq Aesthetics Inc is registered with the FDA (registration 3014214244) in Dublin, CA, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 12, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014214244
- Address
- 6723 Sierra Ct., Dublin, CA, United States, 94568
- Owner or operator
- ZELTIQ Aesthetics, Inc. (10025698)
- Roles
- Manufacturer
- 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 | Manufacturer | accessdata.fda.gov |
| Dermal Cooling Pack/Vacuum/Massager | OOK | 2 | Manufacturer | 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 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 |
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.