Definition: A Fixation Device Is An AC-powered Device Intended For Use As A Fixation Target For The Patient During Ophthalmologic Examination. The Patient Directs His Or Her Gaze So That The Visual Image Of The Object Falls On The Fovea Centralis (the Center Of
| Device Type ID | 4279 |
| Device Name | Device, Fixation, Ac-powered, Ophthalmic |
| Regulation Description | Fixation Device. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 886.1290 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HPL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4279 |
| Device | Device, Fixation, Ac-powered, Ophthalmic |
| Product Code | HPL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Fixation Device. |
| CFR Regulation Number | 886.1290 [🔎] |