HIFU devices. Distinguishing technologies, varieties and marketing labels

The goal of this post is to bring transparency by distinguishing correct technical terms from marketing myths.

HIFU (High-Intensity Focused Ultrasound) is technology widely used for non-invasive lifting in skin care. Unfortunately, its success has led to chaos in the market. Advertisements abound with confusing claims – “the latest generation” HIFU devices, “revolutionary” 4D, 7D, 9D, 12D, 22D, 25D HIFU devices and “certified” HIFU machines. The main problem is that MANUFACTURER, BRAND and MODEL are rarely mentioned, which is the first and strongest indicator of a lack of transparency and clinical evidence.

Technical analysis of HIFU equipment

Instead of talking about vague “generations,” it is more accurate to consider the two main functional types systems that dominate the market based on their mechanism of action and regulatory history.

Type 1: MFU with Visualization (The Pioneer)

The first device to enter aesthetic medicine and receive FDA approval for lifting, is UltherapyIts basic principle is called MFU-V (Microfocused Ultrasound with Visualization).

• Difference: This device uses real-time ultrasound imageIt's like having a GPS while driving: the operator sees on a monitor exactly which layer of tissue he is treating (e.g. 4.5 mm for the SMAS layer, 3.0 mm for the dermis).
• Advantages: This one visualization provides maximum safety and precision, as it allows avoiding nerve areas.
• Disadvantages: The procedure is usually longer and more expensive.

Type 2: MMFU for speed and comfort

The second large group includes popular devices such as Ultraformer, Doublo and their variations. Their technology, often called MMFU (Macro & Micro Focused Ultrasound), works without visualization.

• Difference: The focus here is on treatment speed and reducing discomfort for the patient.
• Advantages: The procedure is faster and more affordable.
• Disadvantages: Since there is no real-time control, the operator relies entirely on his anatomical knowledge. The risk is greater with inexperienced personnel, as there is no direct observation of the tissue reaction.

The choice between these two types of systems comes down to priorities: maximum precision and control (Type 1) or greater speed and comfort of the procedure (Type 2).

The Myth of "Generations"

In aesthetic medicine, the term "generation" is rarely used correctly. When you hear about the “latest generation” HIFU machine, this is usually a marketing label, created to denote a slight upgrade or to position a new device. True innovation must always be proven with clinical data and regulatory approvals (FDA/CE Medical) and not chronological labels.

Debunking Marketing Myths: What Do “D” Numbers Hide?

On the HIFU device market, there are two main groups of designations that are not related to real clinical standards, but are used for product differentiationAll terms like 7D, 9D, 12D, 25D HIFU and similar have no clinical, scientific or regulatory significance. They are not recognized by any international medical authority. It should be clearly distinguished that these designations do not constitute a model or official technology specification, and are generic commercial labels.

1. “D” Designations (7D, 9D, 12D, etc.)

• The letter "D": Comes from Dimension. The original "3D" meant that the device treated tissues in three dimensions (length, width and depth).
• The number (7, 9, 12, 22, 25, etc.): It is used for marketing positioning and distinguishing the device as “more advanced.” In fact, the number reflects the number of cartridges (the cartridge)that the machine supports.

2. “X in 1” Designations (2 in 1, 3 in 1, 5 in 1, 6 in 1)

These labels focus on presenting the device as "more functional" or "more universal" compared to established systems. The designation "X in 1" (e.g. "6 in 1") means number of individual functions or handpieces (HIFU, EMS, Radio Frequency, Cryohead, etc.).

Summary: The designations of “7D”, “9D” and “12D” HIFU are mainly used for product differentiation and market expansion. They do not indicate real clinical effectiveness, safety or an officially recognized technological standard.

New trend: Combined HIFU systems

The market is evolving and today we see devices that combine HIFU with other technologies such as HIFU-RF (radio frequency) or HIFU-EMS (electro-muscular stimulation)The goal is to achieve a synergistic effect: HIFU provides deep tightening, and the additional technology improves surface tone or drainage.

Important for combinations: When choosing such a device, it is important to make sure that both technologies in the machine are clinically proven and they have separate regulatory approvalsSometimes the added feature is just marketing filler that doesn't contribute significantly to the end result, but only increases the price.

Transparency: What does “licensed” and “certified” mean?

The claim about "licensed" or "certified" HIFU device in the descriptions and advertisements is unclear. Therefore, the important question is what is the scope of the certificate – is it a general CE marking (CE general) for an electrical appliance or has it followed the strict procedures for a medical device (CE Medical Device).

In the context of medical equipment, the words certified and licensed are used interchangeably by clinics, but have the same meaning: regulatory approval (i.e., the machine has been checked and approved for use). This means that the device is undergone clinical trials, which prove his efficiency, safety and precisionIt is important to distinguish the general “CE” marking from the strict “CE Medical Device” marking.

Distinguishing CE Markings: “Generic CE” vs. “CE Medical Device”

It is essential to know that only the “CE Medical Device” marking proves clinical suitability, while the general “CE” marking is inherent to all electrical appliances. This is where the confusion in the announcement of certificates comes from.

1. "CE" (Generic) marking

• What is: "Conformité Européenne" - CE Marking (Declaration of Conformity), General Information (Europa.eu).
• Meaning: This marking means that the product (whether it is a toaster, a toy or an aesthetic appliance) complies with minimum safety requirements (electrical, fire, radio frequency) for sale in the EU.
• The problem: It does not require clinical evidence. The manufacturer declares conformity himself. It is this easy to get label used by most cheap devices to make them look legitimate.

2. "CE Medical Device" (Medical Device) marking

• What is: Certificate issued under the EU Medical Devices Regulation (MDR).
• Meaning: This marking certifies that the device is clinically tested and it has been proven that achieves the declared therapeutic goal (in this case – non-invasive lifting of the SMAS layer) safe and effective way.
• The problem: Getting it is a long, expensive and rigorous processwhich only established manufacturers can afford.

The licensed device is the only one that guarantees security through two key factors:

1. Regulatory approvals (FDA / CE Medical)

2. Original consumables

For a more detailed look at how HIFU technologies are evolving in different regions, see: How do the HIFU markets differ in China, the US, Korea and Europe?