DEVICE DETAILS
| NAME OF DEVICE | STARFORMER FAMILY |
|---|---|
| ESTABLISHMENT NAME | VENUSYS MEDICAL SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB3862525-210390 |
| BRAND NAME | FOTONA |
| MEDICAL DEVICE CATEGORY | MD 1103 - Devices for stimulation or inhibition |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Fotona StarFormer is device which is used for muscle strengthening on areas of glutes, abdomen, hamstring area, arms and pelvic floor using High Intensity Magnetic Stimulation (HIMS). Fotona StarFormer will provide a pulsed magnetic field that will through its effect on muscles has been scientifically found that the technology of HIMS will result in increased muscle mass after multiple treatments on the same target location. During the treatment, the patient will either be lying on the therapeutic table or will be sitting on a chair. The procedure will last for about 30 minutes and can be performed for alternate days in a week. Do note that the treatment is non-invasive and the effectiveness of the treatment is not affected by clothes on the patient's body. The Fotona StarFormer magnetic system family consists of: 1) model M008-3T with commercial names - StarFomer - TightWave 2) model M008-5T with commercial name - IntimaWave |
| DEVICE INTENDED PURPOSE | The StarFormer Family of devices and their accessories are intended for magnetic stimulation in the field of Aesthetics, Urology, Gynecology, Rehabilitation, Physiotherapy, and Pain Management. |
| VALIDITY DATE OF REGISTRATION | 04/09/2025 - 03/09/2030 |