The following data is part of a De Novo classification by Zeltiq Aesthetics with the FDA for Zeltiq Aesthetics Dermal Cooling Device.
| DeNovo ID | DEN090002 |
| Device Name: | ZELTIQ AESTHETICS DERMAL COOLING DEVICE |
| Classification | Dermal Cooling Pack/vacuum/massager |
| Applicant | ZELTIQ AESTHETICS 4698 Willow Road Pleasanton, CA 94588 |
| Contact | Louis-pierre Marcoux |
| Product Code | OOK |
| CFR Regulation Number | 878.4340 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K080521 |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Post-NSE |
| Date Received | 2009-10-13 |
| Decision Date | 2010-08-24 |
| Reclassification Order: | Reclassification Order |