De Novo
DEN080006: ULTHERA SYSTEM, MODEL 8850-0001
FDA De Novo · ulthera, inc. · decided Sep 11, 2009
Key facts
| De Novo number | DEN080006 |
|---|---|
| Device name | ULTHERA SYSTEM, MODEL 8850-0001 |
| Applicant | ulthera, inc. |
| Product code | OHV |
| Date received | Apr 11, 2008 |
| Decision date | Sep 11, 2009 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 1012187 |
At a glance
- None Later 510(k)s citing this De Novo
- 10–99 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: