Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
BC-5 Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions. BC-5 Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. BC-5 Red and Blue light in combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. BC-5 Red and Infrared light in combination is intended to emit energy in the red and infrared region of the spectrum to treat dermatological conditions, specifically indicated to treat periorbital wrinkles. BC-5 Infrared is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
BC-5 Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions. BC-5 Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. BC-5 Red and Blue light in combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. BC-5 Red and Infrared light in combination is intended to emit energy in the red and infrared region of the spectrum to treat dermatological conditions, specifically indicated to treat periorbital wrinkles. BC-5 Infrared is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
BC-5 is a light-based photobiomodulation system intended for performing non-invasive, low-level light therapy (LLLT). It is used to deliver visible light wavelengths to treat dermatological conditions or to apply near infrared to the skin for topical heating. BC-5 is a transportable, vertical system with an attached, four-panel treatment head that is manually adjusted to an appropriate distance above the patient's skin. The device does not contact the patient. System components include a mains-powered control unit with touch-input control panel and microprocessor circuit; adjustable treatment head; and base with casters for transportability. An autolift pole connects the treatment head to the top of the main unit. An emergency stop switch allows the user to quickly shut the system down. The technological heart of the system is RGB-IR chips (red-green-blue-near infrared). The user can select from the following five different programs, depending on type of dermatological condition and desired electromagnetic wavelength or combination of wavelengths: red, blue, red and blue, red and infrared, and infrared. The first four are intended to treat skin conditions, while the fifth is intended for topical heating indications. The entire system is reusable and is cleaned before each use.
Summary parsed at:2026-06-01 05:55:37 UTC
