De Novo
DEN200005: Klox Biophotonic LumiHeal System
FDA De Novo · klox technlogies inc. · decided Dec 3, 2021
Key facts
| De Novo number | DEN200005 |
|---|---|
| Device name | Klox Biophotonic LumiHeal System |
| Applicant | klox technlogies inc. |
| Product code | QPE |
| Date received | Feb 4, 2020 |
| Decision date | Dec 3, 2021 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
At a glance
- None Later 510(k)s citing this De Novo
- None 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: