FDA approvals, CE approvals and certifications from other countries do not legally allow you to sell devices here in Australia either. The system MUST be TGA approved to sell it.
The potential destructiveness of HIFU is why devices have to be regulated and why all of InMed Aesthetics devices are TGA approved.
Burns, blistering, tissue destruction are only a few of the side effects of unregulated HIFU systems, if your device is not registered for its intended use then your clinic is potentially opening itself up to massive law suits should client injury occur. Additionally your insurance company could refuse to pay any claims as your device is not properly registered for use within Australia.
This means that you could be personally liable for any and all injury caused to your clients.
As the latest cosmetic treatment, HIFU is an alternative to a surgical face lift.
HIFU is non-invasive with no downtime for the client.
HIFU has many benefits, including:
- Reducing fine lines and wrinkles
- Improvement of the texture of the skin
- Tightening of the neck and jawline
- Lifting the eyebrows, cheeks and eyelids
- Enhancing jawline definition
- Improving the appearance of hooded eyelids and droopy eyes
- Tightening of the décolletage
- Smoothing of the skin
- Treatment of stubborn body fat, skin toning and tightening
HIFU vs. Radiofrequency
RF and HIFU are the two most common technologies for non invasive facial rejuvenation.
On first impressions they both are non surgical, non-invasive tightening treatments that achieve their desired outcomes by inducing collagen remodelling via thermal ablation.
However the two technologies are actually quite different.
R/F skin tightening uses radiofrequency waves in a process called dielectric heating to treat the dermis, or mid layer of the skin. This concentrated heat penetrates no further than about 3mm and causes microscopic contractions to the collagen and increases blood flow to firm the skin and provide a glow from the increased blood flow.
This method however is a bulk heating process and cannot penetrate to the deeper SMAS layer.
HIFU is high intensity focused ultrasound which is highly focused to provide precise tissue heating at varying depths. The ability to change the “target” depth of the HIFU allows for the SMAS layer to be directly targeted for facial rejuvenation or for the fat tissue to be targeted for fat reduction.
The thermal treatments are able to the optimised for your exact patient size and desired outcome.
Radiofrequency cannot treat the SMAS layer and relies on bulk heating to instigate collagen production in the dermis layer. This often requires multiple treatments and ongoing work for lasting results.
HIFU can be performed in one treatment with far fewer follow ups required for patients on the same area.
The deeper penetration to the SMAS layer allows for a better lifting and also wrinkle reduction. R/F used to provide the better outcomes for de-volumisation of tissue areas however with the ability to change focal depths, HIFU is now also providing exceptional results for reducing tissue volume both on the face and throughout the body.