Product code
OTL: Femtosecond laser system for refractive correction
FDA product code · Class III · Ophthalmic
Key facts
| Product code | OTL |
|---|---|
| Device | Femtosecond laser system for refractive correction |
| Device class | Class III |
| Review panel | Ophthalmic |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 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