FlashHeal 2 (FlashHeal 2.0)

FlashHeal's use of blue, red, and infrared regions of the light spectrum is intended to emit energy to treat and document dermatological conditions.

i. The blue light (405 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

ii. The red light (625 nm wavelength) is generally indicated to treat superficial, benign vascular, and pigmented lesions.

iii. The infrared light (850 nm 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.

iv. The red and infrared lights combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

FlashHeal does not diagnose the patient and does not come in contact with the patient at any point.

FlashHeal's use of blue, red, and infrared regions of the light spectrum is intended to emit energy to treat and document dermatological conditions. i. The blue light (405 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. ii. The red light (625 nm wavelength) is generally indicated to treat superficial, benign vascular, and pigmented lesions. iii. The infrared light (850 nm 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. iv. The red and infrared lights combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. FlashHeal does not diagnose the patient and does not come in contact with the patient at any point.

FlashHeal 2 (FlashHeal 2.0 model) is an Rx Only mobile medical device that delivers LED therapies for managing dermatological conditions using various narrow-band wavelengths of blue (405 nm), red (625 nm), and infrared (850 nm) light without any direct patient contact. The light source is placed inside an end-eddector mounted on a mechanical arm maneuvered by the healthcare professional. The system is operated by a touchscreen interface which allows the user to configure the treatment settings.