| Device |
ophthalmodynamometer, diagnostic contact lens, polymethylmethacrylate (pmma) |
| Regulation Description |
Polymethylmethacrylate (PMMA) diagnostic contact lens. |
| Definition |
Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities. The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye. |
| Physical State |
The contact lens consists of a curved shell of acrylic plastic (PMMA), which is adapted with electronic sensors for measurement of pressure applied to the eye. The pressure values are displayed on a LCD display. |
| Technical Method |
The examination PMMA contact lens is adapted with electronic sensors for measurement of pressure applied to the eye. The pressure values are displayed on a LCD display. |
| Target Area |
Eye |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | NYK |
|---|
| Premarket Review |
Ophthalmic Devices
(DHT1A)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.1385
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
