Product code
OOE: Ophthalmic femtosecond laser
FDA product code · Class II · Ophthalmic
Key facts
| Product code | OOE |
|---|---|
| Device | Ophthalmic femtosecond laser |
| Device class | Class II |
| Regulation number | 886.4390 |
| Review panel | Ophthalmic |
| Medical specialty | Ophthalmic |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1,000+ 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