Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Intended to provide light to the body. Generally indicated to dermatology use for the treatment of superficial and pigmented lesions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, or other benign pigmented lesions such as solar lentigines, age spots, or freckles.
Intended to provide light to the body. Generally indicated to dermatology use for the treatment of superficial and pigmented lesions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, or other benign pigmented lesions such as solar lentigo, age spots, or freckles.
The Rogers Sciences Inc.'s Lumina 24 is a light-emitting diode therapy system used to treat superficial and pigmented skin lesions. It consists of a battery-powered light source (Illuminator), optical fibers, and an optical pad (Light Patch). The Light Patch and its adhesive are made from hypoallergenic materials designed to be safe for Fitzpatrick Skin Types II and III. The Lumina 24 system applies Red Light (RL) therapy directly to the treatment area of the skin. To begin treatment, the patient applies the Light Patch to the treatment area and turns on the Illuminator. Light travels from the Illuminator through the optical connector to the Light Patch and to the skin. The Illuminator turns off automatically after 1 hour but treatment may be stopped at any time by turning it off manually. Because Lumina 24 is portable and battery-powered, treatment can take place while the patient is doing other activities.
Summary parsed at:2026-06-01 06:10:03 UTC
