What is missing from most HIFU devices and could this be crucial for the result and safety?

The HIFU procedure promises visible results without surgery, but one key difference in the equipment of HIFU devices remains overlooked – the presence or absence of real-time ultrasound imaging.

What is real-time ultrasound visualization?

This is a technology in which the therapist sees the layers of the skin (epidermis, dermis, SMAS – the superficial muscular-aponeurotic layer) during the procedure. Only with such visualization is it possible to:

• avoid treating at incorrect depth;
• to assess whether the area is suitable for treatment;
• avoid sensitive anatomical structures (e.g. nerves, vessels);
• to individualize the procedure according to the actual anatomy, not according to a predefined template.

Ultherapy® – the standard that is missing from most HIFU devices

Currently Ultherapy® (manufactured by Merz Aesthetics, USA) is the only HIFU device with FDA approval and with patented real-time ultrasound visualization technology. Thanks to this, the specialist can apply the energy precisely to the desired tissues. neither too shallow nor too deep, where the risks are higher.

Source: FDA 510(k) Premarket Notification for the Ulthera® System, which clearly describes that the device includes ultrasound imaging to a depth of 8 mm — this ensures precision and safety of the treatment biospace.com+3accessdata.fda.gov+3accessdata.fda.gov+3

HIFU with ultrasound visualization (Ultherapy®)

Why don't most HIFU devices have this feature?

1. Technology patent – Ulthera Inc. holds the patent for this feature, making its use by other manufacturers limited or impossible without a license.
2. Costs – The imaging technology significantly increases the cost of the device. Ultherapy costs 20-30 times more from typical Chinese machines.
3. Market accessibility – cheap devices (e.g. from Alibaba, DHGate) are mass-produced and sold without clinical studies or certifications from regulatory authorities (such as FDA or CE).

The risk of "blind" work with HIFU apparatus

HIFU without visualization is a procedure in which energy is applied without a clear view of the anatomical layersThis creates a number of potential dangers:

• Thermal burns on the surface or in depth;
• Nerve damage or vessels, especially in the cervical area;
• Asymmetry and volume lossif the energy hits fatty tissue;
• Ineffective resultsif the pulses do not reach the correct layer.

Why do beauticians still use cheap machines?

• Easy access – HIFU Devices can be purchased online, often without the need for medical qualifications.
• Minimal training – short online tutorials or PDF instructions are often offered.
• Focus on profit, not safety – the procedures are advertised massively, without understanding the real anatomy or risks.

What does this mean for the customer?

When undergoing HIFU, ask yourself:

• Is a visualization device used?
• Does the person performing the procedure have medical qualifications?
• Does the device itself have proven origin and certification?

The investment in certified equipment with visualization and a qualified specialist is not a luxury, but a necessity for safety and efficiency.