Product code
ONO: Neurosurgical laser with mr thermography
FDA product code · Class II · Neurology
Key facts
| Product code | ONO |
|---|---|
| Device | Neurosurgical laser with mr thermography |
| Device class | Class II |
| Regulation number | 878.4810 |
| Review panel | Neurology |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database