Manufacturer
Rogers Sciences, Inc.LUMINA 24
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K140386
- Device name
- LUMINA 24
- Company
- Rogers Sciences, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2014-02-14
- Decision date
- 2015-05-26
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
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 Use
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.
Device Description
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
