De Novo
DEN090002: ZELTIQ AESTHETICS DERMAL COOLING DEVICE
FDA De Novo · zeltiq aesthetics · decided Aug 24, 2010
Key facts
| De Novo number | DEN090002 |
|---|---|
| Device name | ZELTIQ AESTHETICS DERMAL COOLING DEVICE |
| Applicant | zeltiq aesthetics |
| Product code | OOK |
| Date received | Oct 13, 2009 |
| Decision date | Aug 24, 2010 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 3007215625 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: