Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4340](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4340) → OOK — Dermal Cooling Pack/Vacuum/Massager

# OOK · Dermal Cooling Pack/Vacuum/Massager

_General, Plastic Surgery · 21 CFR 878.4340 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK

## Overview

- **Product Code:** OOK
- **Device Name:** Dermal Cooling Pack/Vacuum/Massager
- **Regulation:** [21 CFR 878.4340](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4340)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.

## Classification Rationale

Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

## Special Controls

*Classification.* Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K233732](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K233732.md) | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | Sep 12, 2024 | SESE |
| [K212707](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K212707.md) | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. | Nov 5, 2021 | SESE |
| [K193566](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K193566.md) | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Jan 21, 2020 | SESE |
| [K183514](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K183514.md) | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Jan 14, 2019 | SESE |
| [K181740](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K181740.md) | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Aug 29, 2018 | SESE |
| [K172144](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K172144.md) | CoolSculpting System | Zeltiq Aesthetics | Nov 1, 2017 | SESE |
| [K171069](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K171069.md) | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Jul 7, 2017 | SESE |
| [K162050](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K162050.md) | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Nov 21, 2016 | SESE |
| [K160259](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K160259.md) | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Mar 23, 2016 | SESE |
| [K151179](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K151179.md) | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Sep 22, 2015 | SESE |
| [K142491](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K142491.md) | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Jan 26, 2015 | SESE |
| [K133212](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K133212.md) | ZELTIQ COOLSCULPTING SYSTEM | Zeltiq Aesthetics, Inc. | Apr 9, 2014 | SESE |
| [K120023](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/K120023.md) | ZELTIQ COOLSCULPTING | Zeltiq Aesthetics, Inc. | May 2, 2012 | SESE |
| [DEN090002](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/DEN090002.md) | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | Zeltiq Aesthetics | Aug 24, 2010 | DENG |

## Top Applicants

- Zeltiq Aesthetics, Inc. — 11 clearances
- Zeltiq Aesthetics — 2 clearances
- Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK)

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