Definition: The Ophthalmic Conformer With Molded Plastic And Biological Tissue Insert Is Introduced Temporarily Between The Eyeball And Eyelid To Maintain Space In The Orbital Cavity, Prevent Closure Or Adhesions During The Healing Process Following Surgery, And
| Device Type ID | 4388 |
| Device Name | Conformer, Ophthalmic, Biological Tissue |
| Regulation Description | Ophthalmic Conformer. |
| 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) Exempt |
| CFR Regulation Number | 886.3130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NQB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4388 |
| Device | Conformer, Ophthalmic, Biological Tissue |
| Product Code | NQB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ophthalmic Conformer. |
| CFR Regulation Number | 886.3130 [🔎] |