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Ulthera vs. other HIFU / Ultrasound machines?

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?

Doctor Answers 5

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

April 7th, 2015
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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.

Web reference: http://www.goldskincare.com/skin-tightening/

Michael Gold, MD


Nashville Dermatologic Surgeon
4.0 out of 5 stars 18 reviews

April 7th, 2015

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

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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.

Learn more: http://www.goldskincare.com/skin-tightening/

Michael Gold, MD


Nashville Dermatologic Surgeon
4.0 out of 5 stars 18 reviews

I only have experience with Ultherapy for facial tightening and have not used non FDA-cleared devices

March 27th, 2015
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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.

Web reference: http://www.thenyac.com/ultherapy/

Ronald Shelton, MD

Ronald Shelton, MD
Manhattan Dermatologic Surgeon
4.9 out of 5 stars 37 reviews

March 27th, 2015

I only have experience with Ultherapy for facial tightening and have not used non FDA-cleared devices

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}
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.

Learn more: http://www.thenyac.com/ultherapy/

Ronald Shelton, MD

Ronald Shelton, MD
Manhattan Dermatologic Surgeon
4.9 out of 5 stars 37 reviews

Buyer Beware

April 15th, 2015
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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,

Web reference: http://www.mirrormirrorhouston.com/ulthera-lift

Paul Vitenas, Jr., MD
April 15th, 2015

Buyer Beware

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}
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,

Learn more: http://www.mirrormirrorhouston.com/ulthera-lift

Paul Vitenas, Jr., MD

FDA cleared HIFU is Ultherapy

March 18th, 2015
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We cannot comment on copy cat devices. 

In the U.S. Ultherapy is FDA cleared and highly effective and safe with proven results at 5-7 years follow up. 

Read the Ultherapy book on the link below. 

Web reference: http://peacebridgehealthcare.com/flipbooks/ultherapy/ultherapy.html

Hratch Karamanoukian, MD, FACS
March 18th, 2015

FDA cleared HIFU is Ultherapy

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}
We cannot comment on copy cat devices. 

In the U.S. Ultherapy is FDA cleared and highly effective and safe with proven results at 5-7 years follow up. 

Read the Ultherapy book on the link below. 

Learn more: http://peacebridgehealthcare.com/flipbooks/ultherapy/ultherapy.html

Hratch Karamanoukian, MD, FACS

Ultherapy v Other Ultrasound Machines

March 18th, 2015
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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. 

Web reference: http://www.zcosmetichealth.com/cosmetic-procedures-sherman-oaks/ultherapy/

Michael A. Zadeh, MD, FACS
March 18th, 2015

Ultherapy v Other Ultrasound Machines

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}
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. 

Learn more: http://www.zcosmetichealth.com/cosmetic-procedures-sherman-oaks/ultherapy/

Michael A. Zadeh, MD, FACS

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.