| Device |
heat treatment for cold sores herpes simplex virus-1 |
| Definition |
Ends cold sores in half the time as compared to untreated cold sores.This is a treatment of individual herpes labialis lesions in persons infected with the herpes simplex virus. |
| Physical State |
Uses a 1072nm +/- 12nm peak wavelength on a cold sore for a period of approximately 3 minutes. The power source is a standard alkaline 9v battery, which is replaceable. Treatment with the cold sore machine is commenced at the first symptoms of a cold sore and repeated every 12 hours until healing commences. The treatment area is approximately 7 sq cm. The device is activated by the ON button, and automatically powers down after the preprogrammed treatment time (approximately 3 minutes). |
| Technical Method |
Applies low level light to a herpes simplex virus cold sore on the lips. The light shortens the healing time of the cold sore. |
| Target Area |
Lips |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OKJ |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4850
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
