| Device |
light based device for dry age-related macular degeneration |
| Definition |
A light based device for dry age-related macular degeneration is a prescription device intended for use in the application of non- coherent light energy to the eye. The device treats or improves visual acuity in patients with dry age-related macular degeneration. |
| Physical State |
The device is an instrument with non-coherent light sources. The device will center the beam of light on the patient’s eye prior to initiating treatment. |
| Technical Method |
The device emits light in different wavelengths from non-coherent light sources. The system delivers light to the eye in patients with Dry Age-Related Macular Degeneration (AMD). Each treatment may take a few minutes. During the treatment, the patient’s eye may be exposed to light of specific wavelengths while the eye lid is open and/or closed. |
| Target Area |
Eye |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | SDE |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.5520
|
|---|
| 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 |
