| Device |
intense pulsed light device for managing dry eye |
| Regulation Description |
Intense pulsed light device for managing dry eye. |
| Definition |
An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye. |
| Physical State |
IPL applicator. |
| Technical Method |
Intense pulsed light (IPL) applicator is a high-powered, hand-held flashgun to deliver an intense, visible, broad-spectrum pulse of light that targets specific structures and chromophores (e.g., melanin in hair, or oxyhemoglobin in blood vessels) that are heated to destruction and reabsorbed by the body. |
| Target Area |
Malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | QIU |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.5201
|
|---|
| 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 |
