De Novo
DEN040009: HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
FDA De Novo · hamilton thorne biosciences · decided Nov 4, 2004
Key facts
| De Novo number | DEN040009 |
|---|---|
| Device name | HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) |
| Applicant | hamilton thorne biosciences |
| Product code | MRX |
| Date received | Aug 25, 2004 |
| Decision date | Nov 4, 2004 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Obstetrics/Gynecology |
| FEI number | 1221433 |
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: