Data / Medical devices / United States / Zeltiq Aesthetics, Inc.
Zeltiq Aesthetics, Inc.: FDA-registered device maker in Livermore, CA, United States, 4 510(k) clearances
Zeltiq Aesthetics, Inc. is registered with the FDA (registration 3011837770) in Livermore, CA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011837770
- Address
- 7041 Las Positas Road, Livermore, CA, United States, 94551
- Owner or operator
- ZELTIQ Aesthetics, Inc. (10025698)
- Roles
- Manufacturer
- First device listed
- December 2, 2015
- 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 21, 2020 | K193566 | 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 |
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.