Product code
NQE: Microscope, specular
FDA product code · Class II · Ophthalmic
Key facts
| Product code | NQE |
|---|---|
| Device | Microscope, specular |
| Device class | Class II |
| Regulation number | 886.1850 |
| Review panel | Ophthalmic |
| Medical specialty | Ophthalmic |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- None 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