ZELTIQ AESTHETICS DERMAL COOLING DEVICE
Device Facts
| Record ID | DEN090002 |
|---|---|
| Device Name | ZELTIQ AESTHETICS DERMAL COOLING DEVICE |
| Applicant | Zeltiq Aesthetics |
| Product Code | OOK · General, Plastic Surgery |
| Decision Date | Aug 24, 2010 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 878.4340 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Regulatory Classification
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.
