| Device |
light based treatment for cold sores herpes simplex virus-1 |
| Regulation Description |
Light based energy source device for topical application. |
| Definition |
Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization. |
| 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 |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4860
|
|---|
| 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 |
