Device Dossier

Non-sterile scar management dressing, reusable

Device Dossier for Non-sterile scar management dressing, reusable (Non-sterile scar management dressing, reusable, Class IIa, sponsor myscar). ARTG…

Intended purpose

A non-sterile covering made of a 100% medical grade silicone-based material (silicone gel, polyurethane film) intended to be applied directly to the skin for the management of scars including abnormal scars such as hypertrophic and keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. This device is self-adhesive and some are washable. This is a reusable device for up to two weeks.

TGA Public Summary