Definition: To Improve Speed, Accuracy, And Coordination Of Binocular Eye Movements And Changes Of Accommodation. To Treat Poor Accommodation And Vergence Facility, Convergence Insufficiency, And Accommodative Lag.
| Device Type ID | 4393 |
| Device Name | Fixation, Vision Training, Binocular |
| Physical State | Lights Are Spaced Along A Rod Or Positioned Two-dimensionally On A Screen. Various Materials Are Used For The Rod Or Screen. |
| Technical Method | Multiple Fixation Targets Move Or Alternate In Preprogrammed Sequences. |
| Target Area | The Eye |
| 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 | NXR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4393 |
| Device | Fixation, Vision Training, Binocular |
| Product Code | NXR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Fixation Device. |
| CFR Regulation Number | 886.1290 [🔎] |