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U.S. Department of Health and Human Services

Product Classification

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Device light based treatment for cold sores herpes simplex virus-1
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 CodeOKJ
Premarket Review 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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible