Product code
PMW: Strabismus detection device
FDA product code · Class II · Ophthalmic
Key facts
| Product code | PMW |
|---|---|
| Device | Strabismus detection device |
| Device class | Class II |
| Regulation number | 886.1342 |
| Review panel | Ophthalmic |
| Medical specialty | Ophthalmic |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For the automated detection of misalignment of the visual axes for prescription use only. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 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