Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Derrmalux® Tri-Wave MD's use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (633nm wavelength) is generally indicated for treatment of superficial, benign, vascular and pigmented lesions. The near-infrared light (830nm wavelength) is generally indicated 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 Derrmalux® Tri-Wave MD's use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (633nm wavelength) is generally indicated for treatment of superficial, benign, vascular and pigmented lesions. The near-infrared light (830nm wavelength) is generally indicated 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.
Dermalux® Tri-Wave MD is a powered laser surgical instrument that utilizes red, blue, and near-infrared light to treat dermatological conditions. It features a power supply of 100-240Vac, 50/60Hz, and operates with three types of light: red light at 633nm±5nm, blue light at 415nm±5nm, and near-infrared light at 830nm±5nm. The device has four panels that can emit the three lights individually or in combination, with specific output power levels for each wavelength.
Summary parsed at:2026-06-01 05:47:54 UTC
