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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
EL.EN. SPA
M095G1
In Commercial Distribution

  • 08057017760504 ()
M095G1

  • General/multiple surgical diode laser system
The Smartlipo Laser is a Nd:YAG laser system. it emits a 1064nm wavelength. Laser emission activation is by foot switch.
EL.EN. SPA
M053Z1
In Commercial Distribution

  • 08057017760474 ()
M053Z1

  • General/multiple surgical solid-state laser system
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.
EL.EN. SPA
M122B1
In Commercial Distribution

  • 08057017760450 ()
M122B1

  • Multi-modality skin surface treatment system
The TIAC II 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.
EL.EN. SPA
M116H1
In Commercial Distribution

  • 08057017760436 ()
M116H1

  • Microwave hyperthermia system applicator, extracorporeal
The TIAC 1 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.
EL.EN. SPA
M116E1
In Commercial Distribution

  • 08057017760405 ()
M116E1

  • Microwave hyperthermia system applicator, extracorporeal
The DEKA SmartXide² Trio is a medical laser system equipped with a 60W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source.
EL.EN. SPA
M103AE1
In Commercial Distribution

  • 08057017760382 ()
M103AE1

  • General/multiple surgical solid-state/carbon dioxide laser system
The DEKA Motus AY is a medical device quipped with a 755nm and 1064nm solid state laser sources. The laser source delivers the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. Handpiece activation is either by footswitch or fingerswitch.
EL.EN. SPA
M115B1
In Commercial Distribution

  • 08057017760344 ()
M115B1

  • Multi-modality skin surface treatment system
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 4 optical fibres. The operator can use 1 to 4 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.
EL.EN. SPA
M095D1
In Commercial Distribution

  • 08057017760320 ()
M095D1

  • General/multiple surgical diode laser system
The Smartxide TETRA system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delivered to the treatment area through the handpieces or the scanning units.
EL.EN. SPA
M118C1
In Commercial Distribution

  • 08057017760290 ()
M118C1

  • General/multiple surgical carbon dioxide laser system
The SmartXide2 system consists in a 10,600nm carbon dioxide laser (CO2) laser with 60W of maximum power. It can be equipped with an optional diode laser source of 50W maximum power. The laser radiation is delivered to the treatment area through the handpieces or the scanning units. A wide range of handpieces can be provided with the Smartxide² system, having different spot sizes and high performances in specific application fields.
EL.EN. SPA
M103AC1
In Commercial Distribution

  • 08057017760283 ()
M103AC1

  • General/multiple surgical diode/carbon dioxide laser system
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