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The Cold Sore Device is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.

The Cold Sore Device is a solid state opto-electronic device that emits a controlled quantity of 1072nm +/- 12nm peak wavelength near infrared light for a period of approximately 3 minutes. The maximum peak light intensity across the treatment surface is 20mW/cm². The light output and duration are monitored by a microprocessor. The tip of the device that contacts the patient is made out of Acrylonitrile Butadiene Styrene (ABS) + PC. Treatment with the device is commenced at the first symptoms of a cold sore 3 times a day with 4 hours in between each treatment for 2 consecutive days. The treatment area is approximately 3 cm². There are 2 light emitting diodes (LEDs) in the treatment area. The light within the device is activated by opening the cover of the device and automatically shut down after the pre-programmed treatment time (3 minutes). The device is designed for external, limited duration skin contact in an environment free from fluids and is provided non-sterile. The LEDs do not come in direct contact with the patient based upon the design of the device. The device is for OTC use and single patient use as described in the patient and box labeling.

The Cold Sore Device is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.

The Cold Sore Device is a solid state opto-electronic device that emits a controlled quantity of 1072mm +/-12nm peak wavelength near infrared light for a period of approximately 3 minutes. The maximum peak light intensity across the treatment surface is 20mW/cm². The light output and duration are monitored by a microprocessor. The tip of the device that contacts the patient is made out of Acrylonitrile Butadiene Styrene (ABS) + PC. Treatment with the device is commenced at the first symptoms of a cold sore 3 times a day with 4 hours in between each treatment for 2 consecutive days. The treatment area is approximately 3 cm². There are 2 light emitting diodes (LEDs) in the treatment area. The light within the device is activated by opening the cover of the device and automatically shut down after the preprogrammed treatment time (3 minutes). The device is designed for external, limited duration skin contact in an environment free from fluids and is provided non-sterile. The LEDs do not come in direct contact with the patient based upon the design of the device. The device is for OTC use and single patient use as described in the patient and box labeling.

The ViruLite Cold Sore Machine is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.

The ViruLite is a solid state opto-electronic device that emits a controlled quantity of 1072nm +/- 12nm peak wavelength near infrared light for a period of approximately 3 minutes. The maximum peak light intensity across the treatment surface is 20mW/cm². The light output and duration are monitored by a microprocessor. The power source is a standard alkaline 9V battery. which is replaceable. The tip of the device that contacts the patient is made out of Acrylonitiile Butadiene Stvrene (ABS).