| Device |
adaptometer (biophotometer), software-based data acquistion and stimulus generation |
| Regulation Description |
Adaptometer (biophotometer). |
| Definition |
Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light. |
| 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 the only features of the device which are software controlled. |
| Target Area |
Retina and ocular structures |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | OUM |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.1050
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
