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Intended Use: PRIMELASE Excellence is intended for use in dermatologic and general surgical procedures. Indications for Use: PRIMELASE Excellence System with 810nm Laser applicator is intended for: · 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). - · Treatment of benign pigmented lesions PRIMELASE Excellence System with 755nm Laser applicator is intended for: · 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). - · Treatment of benign pigmented lesions PRIMELASE Excellence System with 1060nm Laser applicator is intended for: · 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). · Treatment of benign vascular lesions, including angiomas, telangiectasia, and other benign vascular lesions and leg veins. - Treatment of wrinkles PRIMELASE Excellence System with 810-1060nm Laser applicator is intended for: · 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).

PRIMELASE Excellence is a diode laser device which consists of a central unit and external applicators. The PRIMELASE equipment emits laser radiation (beam infrared light with a wavelength range of 755 nm to 1060 nm, typically and most used 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 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.

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, defmed 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).

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 consist 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.

Indications for use for PRIMELASE diode laser hair removal system with 755mm, 810mm and 810 - 1060mm 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).

PRIMELASE diode laser hair removal system is a medical electrical equipment intended for hair removal treatment, the basic principle of which is selective photothermolysis, which consist 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 PRIMELASE machine consists of a central unit and a set of 5 removable applicators. The PRIMELASE equipment emits laser radiation (beam infrared light with a wavelength range of 755 mm to 1060 nm, typically and most used 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 treatment can be provided in two modes, dynamic and static. Dynamic mode uses the low fluence & high frequency and is used for initial treatments. Static mode uses high fluence & low frequency and is used for residual hair removal. 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