← Back to catalogue

Zeltiq CoolSculpting System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183514

by Zeltiq Aesthetics, Inc.

Identifiers

510(k) Number
K183514 FDA 510(k)
FDA Product Code
OOK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4340 FDA 510(k)
Regulation Number
878.4340 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Zeltiq CoolSculpting System is a dermal cooling pack/vacuum/massager used for cryolipolysis procedures, which selectively targets localized fat deposits and reduces them by chilling them to just above freezing. It is classified as a class 2 device. The system consists of a control unit and surface applicators.

The Zeltiq CoolSculpting System is supplied with various sizes of applicators and is intended for use in general and plastic surgery settings. It has been cleared by the FDA under the special 510K clearance type, with the decision code SESE, and has the regulation number 878.4340. The device is manufactured by Zeltiq Aesthetics, Inc. and has the product code OOK.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Zeltiq Aesthetics - Wikipedia, Zeltiq CoolSculpting - What Is It? Will It Work? Zeltiq Cost Info, ZELTIQ CoolSculpting Breeze System - Swastika Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Zeltiq Aesthetics, Inc.

Sources (1)

  • FDA 510(k) K183514 24 fields · synced Oct 6, 2026