DEVICE DETAILS
| NAME OF DEVICE | LIGHTWALKER |
|---|---|
| ESTABLISHMENT NAME | VENUSYS MEDICAL SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC6207824-164079 |
| BRAND NAME | FOTONA |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Fotona LightWalker laser system incorporates treatment lasers that operate in the invisible near (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, and an aiming beam that operates in the visible range. The system combines one or two (depending on the model) flashlamp-pumped solid-state laser sources in one housing, with optical cavities containing the Nd:YAG and/or Er:YAG crystals. The diode aiming beam, which is a semiconductor diode laser with a wavelength of 650, 635 or 520-532 nm (depending on the model), is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical hand piece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to bare fiber distal end. |
| DEVICE INTENDED PURPOSE | The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynaecology and urology, ENT, surgery and pain management. |
| VALIDITY DATE OF REGISTRATION | 25/02/2024 - 24/02/2029 |