Definition: Measurement Of Retinal Adaptation (regeneration Of The Visual Purple) And Absolute Visible Sensitivity To Light.
| Device Type ID | 4402 |
| Device Name | Adaptometer (biophotometer), Software-based Data Acquisition And Stimulus Generation |
| Physical State | The Device Is Typically Plastic Or Metal Enclosed And Desk Top-based. In The Enclosure Are Electronic Components, Including A Light Source, Measurement Components. And Electronics Containing Software For Data Acquisition And Stimulus Generation. |
| Technical Method | A Light Source Stimulates The Retina And The The Time Required For Retinal Adaptation (regeneration Of The Visual Purple) Is Measured. The Minimum Light Threshold Is Also Determined, In This Same Fashion. Stimulus Generation And Data Acquisition Are |
| Target Area | Retina And Ocular Structures |
| Regulation Description | Adaptometer (biophotometer). |
| 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 | 886.1050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OUM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4402 |
| Device | Adaptometer (biophotometer), Software-based Data Acquisition And Stimulus Generation |
| Product Code | OUM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Adaptometer (biophotometer). |
| CFR Regulation Number | 886.1050 [🔎] |