← Product Code [OOK](/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK) · DEN090002

# ZELTIQ AESTHETICS DERMAL COOLING DEVICE (DEN090002)

_Zeltiq Aesthetics · OOK · Aug 24, 2010 · General, Plastic Surgery · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/DEN090002

## Device Facts

- **Applicant:** Zeltiq Aesthetics
- **Product Code:** [OOK](/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK.md)
- **Decision Date:** Aug 24, 2010
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 878.4340
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/DEN090002](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OOK/DEN090002)

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