Zeltiq Aesthetics, Inc.

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.

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.

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.

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.