elysion-pro

High Technology Products S.L.U

Country / region:Spain (ES)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K193367
Device name
elysion-pro
Country / region
Spain(ES)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-12-04
Decision date
2020-03-12
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

Indications for use for ELYSION diode laser hair removal system with 755nm and 810nm applicators include:
• Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
• Treatment of Pseudofolliculitis barbae (PFB)
• Use on all skin types (Fitzpatrick I-VI).

Intended Use

Indications for use for ELYSION diode laser hair removal system with 755nm and 810nm applicators include: • Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Treatment of Pseudofolliculitis barbae (PFB) • Use on all skin types (Fitzpatrick I-VI).

Device Description

ELYSION diode laser hair removal system is a medical electrical equipment intended for hair removal treatment, the basic principle of which is selective photothermolysis, which consists in the specific destruction of a follicle due to an increase of the temperature induced by a high-powered beam of light which is selectively absorbed by the melanin. The ELYSION equipment consists of a central unit and a set of 3 removable applicators. The ELYSION equipment emits laser radiation (near-infrared light with a wavelength range of 755 nm & 810 nm), pulsed through the laser aperture situated at the tip of the applicator. The device applicator contains the diode which emits the laser energy whereas the power delivered, and the working frequency being controlled by the machine's central unit. The applicator emits the energy through a sapphire window, in contact with the skin throughout the treatment, aimed at damaging the hair follicle. The device has three types of applicators differentiated by the emitted wavelength and the area of emission. Two of the applicators emitting radiation at 810 nm wavelength for two areas 10×10 mm2 and 18×10 mm2 and another one emitting radiation at 755 nm for an area of 10×10 mm2. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-2-3 Hz for static and 5-10-15 Hz for dynamic). The emission of energy is activated in the form of continuous pulses when pressing the applicator button. The applicator sapphire tip is cooled to a constant temperature to cool the skin, so that it partially anaesthetizes the tissue reducing the risk of damage to the epidermis during treatment.

Summary parsed at:2026-06-01 05:47:10 UTC

Predicate devices

3

K193367 references 3 predicate/reference devices

Cited as predicate

3

3 submissions cite K193367 as a predicate