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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 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
The Synchro Repla:y Excellium 3.4 is a medical laser workstation equipped with an High power Alexandrite 755 nm laser and an high power Nd:YAG 1064 nm laser. The system can also be equipped with a pulsed light handpieces.
EL.EN. SPA
M104K1
In Commercial Distribution

  • 08057017760108 ()
M104K1

  • Multi-modality skin surface treatment system
The smart US-20D system consists in a carbon dioxide laser (CO2) with 25W of maximum power. The CO2 laser radiation is delivered to the treatment area through handpieces or a scanning unit (DOT scanner).
EL.EN. SPA
M079B1
In Commercial Distribution

  • 08057017760092 ()
M079B1

  • Dermatological carbon dioxide laser system
The Smartxide 50 system consists in a carbon dioxide laser (CO2) with 50W of maximum power. The CO2 laser radiation is delivered to the treatment area through handpieces or a scanning unit (DOT scanner).
EL.EN. SPA
M079AL1
In Commercial Distribution

  • 08057017760085 ()
M079AL1

  • Dermatological carbon dioxide laser system
The Smartxide system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delivered to the treatment area through handpieces or a scanning unit (DOT scanner).
EL.EN. SPA
M079R1
In Commercial Distribution

  • 08057017760078 ()
M079R1

  • Dermatological carbon dioxide laser system
The Smartfile medical system is a Nd:YAG laser device for treatment of dental desease. The laser radiation is delivered to the treatment area through the handpieces.
EL.EN. SPA
M077C2
Not in Commercial Distribution

  • 08057017760054 ()
M077C2

  • Dental solid-state laser system
The Cynosure SLT II workstation has a solid state Nd:YAG laser capable of emitting laser radiation in three wavelenghts and includes a wide range of different delivery system, handpieces, fibers, cannulas and other accessories.
EL.EN. SPA
M094E1
In Commercial Distribution

  • 08057017760009 ()
M094E1

  • General/multiple surgical solid-state laser system
Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the data to the host.
CARDIOLINE SPA
HD+
In Commercial Distribution

  • 08056732654594 ()
81018027

  • Multichannel electrocardiograph, signal-averaging
12‐lead high‐performance, multi‐channel, interpretative resting electrocardiograph which displays, acquires, prints and stores ECG tracings for adults and children. 4.3" display and 100mm printer paper.
CARDIOLINE SPA
ECG100+
In Commercial Distribution

  • 08056732653610 ()
80508095

  • Electrocardiograph, professional, multichannel
Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth or USB, sends the data to the host.
CARDIOLINE SPA
HD+12
In Commercial Distribution

  • 08056732652422 ()
81018331

  • Electrocardiograph, professional, multichannel
ATTIVA is a Radiofrequency (RF) System (generator, electrodes/handpieces and accessories) indicated for treatments based on the emission of electromagnetic waves that lead to a rise of internal temperature of tissues involved in the treatment for electrocoagulation and hemostasis. ATTIVA device can be used on adult patients only. It comprises of a base unit, activation pedal, ground pad (K203494), endodermic handpiece, thermal camera (K033967) and monitor, and blunt cannulas and RF electrodes.
ITALIAN ENGINEERING SRL
MD01
In Commercial Distribution

  • 08055510890087 ()

  • Weight: 5.8 Kilogram
  • Length: 38.5 Centimeter
  • Height: 10 Centimeter
  • Width: 20.5 Centimeter


  • Percutaneous radio-frequency ablation system generator
Vision-S 700 is a Compact Refraction System used to determine the refractive error and binocular
ESSILOR INTERNATIONAL
VS01012
In Commercial Distribution

  • 03615020000687 ()


  • Phoropter, electric
Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.
ESSILOR INTERNATIONAL
VRS001
In Commercial Distribution

  • 03615020000670 ()


  • Visual acuity light box
Stereomicroscopic observation of the eye subjected to light through a slot Microscopic study of the fundus and posterior vitreous (via a lens Hubry) The ophthalmic evaluation and positioning of the contact lens This product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye).
ESSILOR INTERNATIONAL
SL550L
In Commercial Distribution

  • 03615020000366 ()


  • Ophthalmic examination slit lamp
Stereomicroscopic observation of the eye subjected to light through a slot Microscopic study of the fundus and posterior vitreous (via a lens Hubry) The ophthalmic evaluation and positioning of the contact lens This product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye).
ESSILOR INTERNATIONAL
SL500L
In Commercial Distribution

  • 03615020000359 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL300L
Not in Commercial Distribution

  • 03615020000281 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL300H
Not in Commercial Distribution

  • 03615020000274 ()


  • Ophthalmic examination slit lamp
Retina 400 is an electromedical system that allows for digitally retrieving, acquiring and processing of a retinal image, for use in ophthalmological diagnosis by medical specialists, and other uses inherent to the professional activity of other operators, optometrists and opticians, to the extent permitted by the laws and regulations for the exercise of their profession. An absolute new entry in the field for retinal imaging, the instrument allows for a direct, "live" monitoring on the computer screen, and capturing also in cases where the pupil diameter is extremely narrow. The instrument, with manual acquisition and electronically guided control, guarantees high precision and repeatability of the measurements.
ESSILOR INTERNATIONAL
RETINA 400
In Commercial Distribution

  • 03615020000267 ()


  • Ophthalmic fundus camera
This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis. It also performs automatic discrimination of progressive lens, pupillary distance (PD) measurement of glass lens, UV cut percentage measurement, blue light which harmful to eyes cut percentage measurement, blue light transmittance measurement which necessary to adjust the circadian rhythm
ESSILOR INTERNATIONAL
ALM800
In Commercial Distribution

  • 03615020000236 ()


  • Automated lensmeter
Neuronaute - IceAdapter is a cable that enables to plug the Neuronaute IceCap electrodes with another DB25 cable and be connected to a compatible EEG monitoring system.
BIOSERENITY MEDICAL DEVICES GROUP
1001-15020-US
Not in Commercial Distribution

  • 03615220003471 ()


  • Electroencephalographic electrode cap, single-use
It enables the connection of the Neuronaute Head Module and the Neuronaute High Capacity battery module to the Neuronaute IceCap or a specific set of reusable cup electrodes manufactured with Ag/AgCl discs connected to a lead wire. The wire is insulated and terminates with a touch proof connector (DIN 42802)
BIOSERENITY MEDICAL DEVICES GROUP
1001-15015-US
Not in Commercial Distribution

  • 03615220001781 ()


  • Electroencephalographic monitoring system
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