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?
Answer: Ultherapy vs. other HIFU devices? Which is best? 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!
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Answer: Ultherapy vs. other HIFU devices? Which is best? 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!
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March 16, 2017
Answer: The Ulthera device is the only FDA-cleared HIFU device in the US 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.
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March 16, 2017
Answer: The Ulthera device is the only FDA-cleared HIFU device in the US 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.
Helpful 5 people found this helpful