FDA.reportPublic FDA data

EL.EN. SPA

GUDID#

EXIRA - The EXIRA is a medical laser equipped with:- Alexandrite 755 nm laser, that is a high power laser to remove hair and treat benign pigmented lesions effectively. The wavelength of 755nm is the most suitable for hair removal, especially for the skin types up to Fitzpatrick Type III, due to its high melanin absorption. Skin types more than III can be treated using a more careful procedure or Nd:YAG.- Nd:YAG 1064nm laser, that is a high power laser for effective treatments of vascular lesions and hair removal on all skin types. The wavelength of 1064nm is the most suitable fore removing vascular lesions, due to its high hemoglobin absorption capacity. The 1064nm wavelength has also good absorption in melanin, making the 1064nm the right hair removal solution for all types of skins.A suitable skin cooling system shall be used during laser treatments. The laser handpieces shall be used in conjuction with an external air cooling device.

EL.EN. SPA

2026-02-16

DEKA TRUIST - The DEKA TRUIST 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 filterEmission activation is either by footswitch or fingerswitch.Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.

EL.EN. SPA

2023-04-27

DEKA HELIX - The Helix system consists of:• Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)• LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system.• Two wavelengths – CO2 and 1570 nm• Articulated arm• Footswitch• Delivery devices (CO2 non-fractional applicators, Scanner CO2/1570nm fractional applicator)

EL.EN. SPA

2023-03-21

Elite iQ - 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

2020-03-13

Elite iQ - 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

2020-03-13

DEKA LUXEA - 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 filterEmission activation is either by footswitch or fingerswitch.Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.

EL.EN. SPA

2020-01-15

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