DEVICE DETAILS
| NAME OF DEVICE | STARWALKER |
|---|---|
| ESTABLISHMENT NAME | VENUSYS MEDICAL SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC867531130918 |
| BRAND NAME | FOTONA |
| MEDICAL DEVICE CATEGORY | MD 1402 - Devices utilising non-ionizing radiation |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | STARWALKER FEATURES 12 LASER TREATMENT MODES OPERATING AT 4 COMPLEMENTARY LASER WAVELENGTHS.BASED ON REVOLUTIONARY ASP (ADAPTIVE STRUCTURED PULSE) TECHNOLOGY, STARWALKER IS CAPABLE OF DELIVERING UP TO NA UNPRECEDENTED 10 J OF Q-SWITCHED ENERGY IN ONE GIANT STRUCTURED MAQX (MODULATED ACOUSTICS Q-SWITCHED) PULSE. THE UNIQUE MAQX HIGH ENERGY CAPABILITY OF STARWALKER ENABLES THE GENERATION OF A HIGHER ENERGY PHOTOACOUSTIC EFFECT AT THE TREATMENT SITE, LEADING TO MORE EFFECTIVE AND FASTER TREATMENTS. ADDITIONALLY, WITH HIGH MAQX ENERGIES, LARGER SPOTSIZES CAN BE USED RESULTING IN MORE HOMOGENOUS TREATMENTS OF EVEN DEEPER LYING SKIN PIGMENTS, AND THEREFORE WITH REDUCED RISK OF UNWANTED SIDE EFFECTS. |
| DEVICE INTENDED PURPOSE | FOTONA STARWALKER LASER SYSTEM AND ITS ACCESSORIES ARE INTENDED FOR TATTOO REMOVAL, TREATMENT OF PIGMENTED AND VASCULAR LESIONS, SURGICAL AND AESTHETIC APPLICATIONS REQUIRING SELECTIVE PHOTOTHERMOLYSIS OF TARGET CHROMOPHORES IN SOFT TISSUE, AND INCISION/EXCISION, ABLATION AND VAPORIZATION OF SOFT TISSUE IN GENERAL DERMATOLOGY. |
| VALIDITY DATE OF REGISTRATION | 11/10/2023 - 10/10/2028 |