| Device |
digital therapy device for amblyopia |
| Definition |
A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia. |
| Physical State |
Therapeutic algorithms delivered by software. The software needs to work with a visual display, either third-party or integrated hardware. The visual display may be a head-mounted display, tablet, computer screen, etc. |
| Technical Method |
The device digitally modifies images or videos such that they are perceived differentially by the amblyopic eye and the fellow eye. The image or video modifications penalize the fellow eye (e.g., by reducing contrast or visibility) and, therefore, encourage the use of the amblyopic eye. The device may apply digital masks on the images or videos for both eyes. The pattern of the mask for one eye is complementary to that for the other eye to encourage binocular fusion. |
| Target Area |
Eye |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | QQU |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.5500
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
