EL.EN. SPA

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- Catalog Number : M081AN1

Device Description : The Thermaeye Plus is a pulsed light system having a Xenon flashlamp located in The Thermaeye Plus is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200nm. Emission activation is by footswitch. Overall weight of the system is 16kg, and the size is 22x37x45cm (HxWxD).Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

- Catalog Number : M122B1

Device Description : The Elite iQ™ workstation is a dual wavelength system that delivers laser energy The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase. The Elite iQ delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin. The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

- Catalog Number : M122D1

Device Description : The Elite iQ™ workstation is a dual wavelength system that delivers laser energy The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase (M122D1 model). The Elite iQ delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin. The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

- Catalog Number : M053Z1

Device Description : The Smartlipo Laser is a Nd:YAG laser system. it emits a 1064nm wavelength. Lase The Smartlipo Laser is a Nd:YAG laser system. it emits a 1064nm wavelength. Laser emission activation is by foot switch.

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

- Catalog Number : M120F1

Device Description : The PHYSIQ is a system provided with 4 IR LED to provide topical heating for the The PHYSIQ is a system provided with 4 IR LED to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscles.A LED mounted on top of each handpiece is lighted when the handpiece is emitting.

Device Class : 2

Duns Number: 436887608

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

- Catalog Number : M095G1

Device Description : The ECHOLASER X4 is a medical device equipped with a diode laser source emitting The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via 1 to 2 optical fibres. The operator can use 1 to 2 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

- Catalog Number : M116I1

Device Description : The NEAUVIA CELL is a medical device that used high frequency RF currents to pro The NEAUVIA CELL is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

- Catalog Number : M128A1

Device Description : The DEKA SmartPerio is a Nd:YAG laser device for soft tissues intraoral treatmen The DEKA SmartPerio is a Nd:YAG laser device for soft tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip.

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX, NVK

Prescription Use : Yes

Device Count : 1

- Catalog Number : M120F1

Device Description : The PHYSIQ is a device provided with 4 handpieces by 2 electrodes each intended The PHYSIQ is a device provided with 4 handpieces by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GZJ, IPF

Prescription Use : Yes

Device Count : 1

- Catalog Number : M103AK1

Device Description : The IMLIGHT CO2 Laser is a medical laser system equipped with a 40W CO2 laser so The IMLIGHT CO2 Laser is a medical laser system equipped with a 40W CO2 laser source delivered through a hollow fiber.

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1