Intelligent Sensory Concept SA
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Treatment of periorbital wrinkles; Temporary relief of minor muscle & joint pain, arthritis and muscle spasm, and relieving stiffness; Treatment of mild to moderate forms of acne; Treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris; The intended use of the eLyx PRO is a combination of the intended use of its predicates.
Elyx PRO is intended to emit energy in the blue & red region of the spectrum for use in dermatology for treatment of mild to moderate forms of acne. Elyx PRO is intended to emit energy in the red & near-infrared region of the spectrum for use in dermatology for treatment of periorbital wrinkles. Elyx PRO is intended to emit energy in the red & near-infrared region of the spectrum for temporary relief of minor muscle & joint pain, arthritis and muscle spasm, and relieving stiffness. Elyx-PRO targeted population is adult man & woman (except pregnant woman), and it is intended to be used on both face & body (contraindication on broken or damaged skin nor mucosal).
Elyx-PRO is a professional photomodulation device designed for use in health office. It offers 6 preprogrammed treatment protocols using Light Emitting Diodes (LED) technology. It is composed of a base unit containing power supply, a flexible arm and a light emitting head containing (162 blue 470 nm, 180 red 645 nm and 126 infrared 850 nm). The user interface is accessed via Wi-Fi from any multimedia support with a browser. The LED photomodulation principle is to use LEDs of specific wavelengths and to select accurate stimulation parameters (duration, distance, optical power…) to stimulate targeted biological mechanisms and obtain desired clinical effects.
Summary parsed at:2026-06-01 05:59:07 UTC
