Xemis Medical Technology (Shenzhen) Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Photon therapy apparatus use of the red, blue, yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The red light (633±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light (417±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. The infrared light (830±8nm wavelength) is generally used 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.
Photon therapy apparatus use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The red light (633±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light (417±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. The infrared light (830±8nm wavelength) is generally use 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.
The photon therapy apparatus (BL-10) use specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±8nm), in the blue light regions of the light spectrum (417±8nm), yellow light area (590±8nm) and infrared light region of light spectrum (835±8nm). The photon therapy apparatus (BL-10) are equipped with six type of optional irradiators, each of which emits three different colors of light sources.
Summary parsed at:2026-06-01 05:21:56 UTC
