Device Dossier

Vacuum suction body contouring system

Device Dossier for Vacuum suction body contouring system (Vacuum suction body contouring system, Class IIa, sponsor Vision Aesthetics). ARTG record,…

Intended purpose

The ICOONE® Laser Med device is intended for use on intact cutaneous and subcutaneous tissues for physical therapy and rehabilitation purposes. The device delivers controlled mechanical micro-stimulation through motor-driven rollers combined with vacuum-assisted technology to support connective tissue mobilisation. The device is intended to assist in: Support and temporary improvement of lymphatic flow within the treated area Support of local microcirculation Management of conditions associated with lymphatic and venous insufficiency Support of connective tissue mobility in cases of fibrosis and scar outcomes Temporary relief of mild muscular discomfort Reduction of muscle tightness associated with minor muscular tension Short-term support of local circulation during rehabilitation Temporary relief of mild muscular discomfort associated with delayed onset muscle soreness (DOMS) The device operates exclusively on intact skin, does not breach the skin barrier and does not deliver invasive energy into the body. The device is intended for use in rehabilitation centres and physiotherapy clinics by trained healthcare professionals and physical therapists. The device is not intended to replace standard medical treatment.

TGA Public Summary