DEVICE DETAILS
| NAME OF DEVICE | XS DYNAMIS |
|---|---|
| ESTABLISHMENT NAME | VENUSYS MEDICAL SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC7320085916 |
| BRAND NAME | FOTONA |
| MEDICAL DEVICE CATEGORY | MD 1202 - Imaging devices utilising non-ionizing radiation |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | THIS DEVICE IS A MEDICAL LASER DEVICE WHICH CONSISTS OF ER:YAG LASER WITH A WAVELENGTH OF 2940NM. WITH ADVANCED TREATMENT ATTRIBUTES AND FULLY CUSTOMIZABLE SETTINGS, FOTONA’S XS DYNAMIS OFFERS TRUE 3RD GENERATION ER:YAG LASER SKIN RESURFACING. THE XS DYNAMIS REPRESENTS A COMPLETE REJUVENATION SOLUTION. ITS FUNCTIONS RANGE FROM SUPERFICIAL TO DEEP PEELS, FROM NON-ABLATIVE TO FULLY ABLATIVE AND FROM FULL-FIELD TO FRACTIONAL RESURFACING. |
| DEVICE INTENDED PURPOSE | THIS MEDICAL LASER DEVICES CAN BE USED FOR MANY DIFFERENT APPLICATION IN DERMATOLOGY, GYNECOLOGY AND SURGERY. IT IS APPLICABLE ON ANY LESION WHICH NEEDS TO BE ABLATE OR CUT AS WELL AS COLLAGEN STIMULATION. INDICATIONS INCLUDE SUPERFICIAL SKIN PIGMENTATION, WRINKLES, SKIN TAGS, AND STRESS URINARY INCONTINENCE AND ETC. |
| VALIDITY DATE OF REGISTRATION | 10/11/2021 - 09/11/2026 |