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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 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.
EL.EN. SPA
M116I1
In Commercial Distribution

  • 08057017760511 ()
M116I1

  • Microwave hyperthermia system applicator, extracorporeal
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 (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.
EL.EN. SPA
M122D1
In Commercial Distribution

  • 08057017760467 ()
M122D1

  • Multi-modality skin surface treatment 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 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.
EL.EN. SPA
M081AN1
In Commercial Distribution

  • 08057017760443 ()
M081AN1

  • Multi-modality skin contouring 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 DEKA LUXEA is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application. The available handpieces are: - VIVID: 808±10 nm Laser - SPARKS: 1064nm Laser - PRISMA: 1064nm Q-Switched laser - VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter - LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters - RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550nm filter - LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filter Emission activation is either by footswitch or fingerswitch. Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.
EL.EN. SPA
M117B1
In Commercial Distribution

  • 08057017760429 ()
M117B1

  • Multi-modality skin surface treatment system
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 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source.
EL.EN. SPA
M103AF1
In Commercial Distribution

  • 08057017760399 ()
M103AF1

  • General/multiple surgical solid-state/carbon dioxide laser system
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 Minisilk-FT 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.
EL.EN. SPA
M081R1
In Commercial Distribution

  • 08057017760337 ()
M081R1

  • Multi-modality skin contouring 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 Touch system consists in a carbon dioxide laser (CO2) with 60W of maximum power. The CO2 laser radiation is delivered to the treatment area through the handpieces or the scanning units.
EL.EN. SPA
M110H1
In Commercial Distribution

  • 08057017760313 ()
M110H1

  • General/multiple surgical carbon dioxide laser system
The Smartxide Tetra system consists in a carbon dioxide laser (CO2) with 50W of maximum power. The CO2 laser radiation is delivered to the treatment area through the handpieces or the scanning units.
EL.EN. SPA
M118D1
In Commercial Distribution

  • 08057017760306 ()
M118D1

  • General/multiple surgical carbon dioxide 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
The SmartXide2 system consists in a 10,600nm carbon dioxide laser (CO2) laser with 80W 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 field.
EL.EN. SPA
M103AB1
In Commercial Distribution

  • 08057017760276 ()
M103AB1

  • General/multiple surgical diode/carbon dioxide laser system
The DEKA SmartXide² system is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source. The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory connected to its distal end. The DEKA SmartXide 2 CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator. The diode laser source can be provided in two alternative wavelengths: 940nm and 980nm. The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces.
EL.EN. SPA
M103K1
In Commercial Distribution

  • 08057017760269 ()
M103K1

  • General/multiple surgical solid-state/carbon dioxide laser system
The DEKA SmartXide² system is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source. The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory connected to its distal end.The DEKA SmartXide² CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator. The diode laser source can be provided in two alternative wavelengths: 940nm and 980nm. The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces.
EL.EN. SPA
M103J1
In Commercial Distribution

  • 08057017760252 ()
M103J1

  • General/multiple surgical solid-state/carbon dioxide laser system
DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.
EL.EN. SPA
M110G1
In Commercial Distribution

  • 08057017760245 ()
M110G1

  • Dental carbon dioxide laser system
The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. 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
M112B1
In Commercial Distribution

  • 08057017760221 ()
M112B1

  • Dermatological solid-state laser system
The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG Laser source.
EL.EN. SPA
M080K1
In Commercial Distribution

  • 08057017760214 ()
M080K1

  • Musculoskeletal infrared phototherapy unit, non-wearable
The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG laser sources.
EL.EN. SPA
M077H3
In Commercial Distribution

  • 08057017760207 ()
M077H3

  • Musculoskeletal infrared phototherapy unit, non-wearable
The SmartXide Touch system consists in a carbon dioxide laser (CO2) with 60W of maximum power. The CO2 laser radiation is delivered to the treatment area through the handpieces or the scanning units.
EL.EN. SPA
M110C1
In Commercial Distribution

  • 08057017760153 ()
M110C1

  • Dermatological carbon dioxide laser system
The SmartXide² system consists in a carbon dioxide laser (CO2) laser with 60W of maximum power. The CO2 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 field.
EL.EN. SPA
M103P1
In Commercial Distribution

  • 08057017760146 ()
M103P1

  • Dermatological carbon dioxide laser system
The Cynosure Smartskin+ system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delivered to the treatment area through an handpiece or a scanning unit.
EL.EN. SPA
M079AZ1
In Commercial Distribution

  • 08057017760139 ()
M079AZ1

  • Dermatological carbon dioxide laser system
The Synchro Repla:y Premium 1.4.2 is a medical laser workstation equipped with an High power Alexandrite 755 nm laser. The system can also be equipped with a pulsed light handpieces.
EL.EN. SPA
M104J1
In Commercial Distribution

  • 08057017760122 ()
M104J1

  • Multi-modality skin surface treatment system
The Synchro Repla:y Excellium HP is a medical laser workstation equipped with an high power Nd:YAG 1064 nm laser. The system can also be equipped with a pulsed light handpieces.
EL.EN. SPA
M104L1
In Commercial Distribution

  • 08057017760115 ()
M104L1

  • Multi-modality skin surface treatment system
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