De Novo
DEN150005: Newa Skin Therapy System
FDA De Novo · endymed medical ltd. · decided Dec 18, 2015
Key facts
| De Novo number | DEN150005 |
|---|---|
| Device name | Newa Skin Therapy System |
| Applicant | endymed medical ltd. |
| Product code | PAY |
| Date received | Jan 16, 2015 |
| Decision date | Dec 18, 2015 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 3008085016 |
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: