Manufacturer
Intelligent Sensory Concept SAeLyx-PRO
Intelligent Sensory Concept SA
Country / Region:Switzerland (CH)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K162851
- Device name
- eLyx-PRO
- Country / Region
- Switzerland(CH)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-10-11
- Decision date
- 2017-01-24
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Acne treatmentSkin tightening
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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).
Device Description
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
