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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 the time to healing 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 CodeOKJ
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
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
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