Luminance RED Cold Sore Device
The Luminance RED Cold Sore Device delivers near-infrared light to herpes simplex lesions on and around the lips. It is intended to shorten healing time, defined by patient-reported…
Light Based Treatment for Cold Sores Herpes Simplex Virus-1
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Guangdong.
- Shenzhen Kaiyan Medical Equipment Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.
How Is OKJ Classified?
Light Based Treatment For Cold Sores Herpes Simplex Virus-1 is FDA product code OKJ, Class 2, 21 CFR 878.4860.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 133 days from receipt to decision.