| Device Type ID | 4375 |
| Device Name | Expander, Tissue, Orbital |
| Regulation Description | Eye Sphere Implant. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.3320 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NFM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4375 |
| Device | Expander, Tissue, Orbital |
| Product Code | NFM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Eye Sphere Implant. |
| CFR Regulation Number | 886.3320 [🔎] |