DEVICE DETAILS
| NAME OF DEVICE | ULTRAFORMER MPT |
|---|---|
| ESTABLISHMENT NAME | ANDAMAN MEDICAL BRIDGE SDN. BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC9728724-174234 |
| BRAND NAME | NOT APPLICABLE |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | ULTRAFORMER MPT is an assembly of devices designed to produce and control the delivery of high heat to the body using ultrasonic energy for the intracorporeal treatment of skin lifting and tightening. Higher ultrasound frequencies have more superficial tissue effects and lower frequencies have deeper tissue effects. When ultrasound waves are micro-focused to a point in living tissue, molecular vibration results and heat is generated creating well-defined thermal injury zones at predetermined depths while leaving the surrounding tissue unaffected. The feature directs acoustic waves to the treatment area. This acoustic energy heats tissue as a result of frictional losses during energy absorption, producing discrete points of coagulation. |
| DEVICE INTENDED PURPOSE | The ULTRAFORMER MPT is a non-invasive therapeutic device for skin lifting and tightening. The information regarding the categories of users: Education: Medical doctor Knowledge: Medical knowledge of the skin Language understanding: English or languages offered in the instruction for use. |
| VALIDITY DATE OF REGISTRATION | 30/05/2024 - 29/05/2029 |