Product code
OUM: Adaptometer (biophotometer), software-based data acquisition and stimulus generation
FDA product code · Class I · Ophthalmic
Key facts
| Product code | OUM |
|---|---|
| Device | Adaptometer (biophotometer), software-based data acquisition and stimulus generation |
| Device class | Class I |
| Regulation number | 886.1050 |
| Review panel | Ophthalmic |
| Medical specialty | Ophthalmic |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light. |
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
- None 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