Ulthera vs. other HIFU / Ultrasound machines?

Question

I went to two doctors to compare ultrasound treatments. The first recommended using the original Ultherapy. The second uses the Doublo machine by a korean company Hironic and stated that this is a second generation of ultrasound with less pain than Ulthera, no numbing cream required, more settings for the face and more cheap. Which treatment would you recommend using? Do you have any experience with other machines than Ultherapy?

Ron Shelton, MD · Answer

The only procedures that seem to help tighten tissues in one treatment seem to induce some discomfort whereas other devices that treat externally, as a series of treatments, can heat more gently and cause less to little discomfort.  If a device claims to give as good results in one treatment as Ultherapy and it delivers focused ultrasound energy, I would be skeptical of the effectiveness.  I have found one Ultherapy treatment to provide some lifting and tightening to many of my patients in NYC but I also have seen series of ThermiSmooth and Pelleve treatments help. As an aside, I don't use numbing cream for Ultherapy patients who are receiving more than the 1.5mm deep transducers, as the numbing cream won't decrease the discomfort from the 3 and 4.5mm deep transducers, which are the more commonly used tips to provide deeper tightening.The information provided in Dr. Shelton's answer is
for educational purposes only and is not intended to constitute
medical advice.  The information provided should not be relied upon
as a substitute for consultations with a qualified health professional
who may be familiar with your individual medical needs.

Paul Vitenas, Jr., MD · Answer

The use of Non-FDA Approved prescriptive devices in this country is prohibited and as such we cannot comment on them. That being said Ultherapy is the gold standard in noninvasive skin tightening/ lifting. Huge amounts of research have been done on the technology in order for it to receive its FDA indication and I have seen excellent results with the technology in my practice.Best of luck,

Michael A. Zadeh, MD, FACS · Answer

In the United States, the Ultherapy device by Ulthera is the ONLY Ultrasound focused treatment that is FDA approved to lift, tone, and tighten skin. The Doublo machine is a knock-off. It is not approved for use in the United States by the FDA and it's safety and efficacy have not been determined.

Mark A. Blair, MD · Answer

Hello, Thank you for your question.  Ultherapy is the only FDA approved device for tightening of the skin on the face and décolleté'.  The other device you may have been offered, probably does not go as deep as the Ultherapy device, but keep in mind, with the Ultherapy device many do not "topically numb" with cream anyway because the energy bypasses the surface and is delivered deep in the tissue.  Be careful to choose a experienced provider and device that is FDA approved.

Thanks!

Michael H. Gold, MD · Answer

Thanks for your
question. The Ulthera device is the only FDA-cleared HIFU device at this time
in the United States. In other parts of the world, there are other HIFU devices
that are approved in some countries and are being used by some practitioners.
These devices, like the one you are describing, have no U.S. studies for us to
evaluate their effectiveness or to determine if they are safe to use in all
that are being treated with them. The reality is that getting a CE clearance is
not that difficult and in some instances, safety data is not totally complete. The
U.S. FDA is much more stringent in safety and efficacy, plus there are patent
issues with Ulthera and the other HIFU devices that still need to be addressed
in the U.S.

What I always tell
patients when asked questions like this is that this is buyer beware – we know
Ulthera inside and out – we don’t know the others that well and since they are
not FDA cleared, we do not use them, we do not recommend them, and in the US
they are considered illegal at this time.

Ulthera vs. other HIFU / Ultrasound machines?

Answers (6)

Answer: Ultherapy vs. other HIFU devices? Which is best?

Answer: Ultherapy vs. other HIFU devices? Which is best?

Answer: The Ulthera device is the only FDA-cleared HIFU device in the US

Answer: The Ulthera device is the only FDA-cleared HIFU device in the US

Recommended reading

Everything you need to know about Ultherapy

Our mission is to create a world where every investment in modern beauty is Worth It.

Ulthera vs. other HIFU / Ultrasound machines?

Answers (6)

Answer: Ultherapy vs. other HIFU devices? Which is best?

Answer: Ultherapy vs. other HIFU devices? Which is best?

Answer: The Ulthera device is the only FDA-cleared HIFU device in the US

Answer: The Ulthera device is the only FDA-cleared HIFU device in the US

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Recommended reading

Everything you need to know about Ultherapy

Our mission is to create a world where every investment in modern beauty is Worth It.