Definition: For Implantation To Reinforce And Aid In Reconstruction Of The Soft Tissues Of The Eyelid.
| Device Type ID | 4392 |
| Device Name | Prosthesis, Eyelid Spacer/graft, Biologic |
| Physical State | Lyophilized Sheets Of SIS Cut To Various Sizes |
| Technical Method | Natural Collagen Matrix Which Reinforces Tissue And Promotes Cellular Ingrowth |
| Target Area | Eyelid, Eyelid Area |
| 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 | NXM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4392 |
| Device | Prosthesis, Eyelid Spacer/graft, Biologic |
| Product Code | NXM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ophthalmic Conformer. |
| CFR Regulation Number | 886.3130 [🔎] |