Michael Barbella, Managing Editor02.10.21
There's another tool in the arsenal to improve the appearance of unsightly cellulite.
The U.S. Food and Drug Administration (FDA) recently cleared Soliton Inc.'s Rapid Acoustic Pulse (RAP) technology for the short-term improvement in the appearance of cellulite.
"We're thrilled to receive this latest clearance for our RAP technology," said Brad Hauser, president and CEO of Soliton. "Our technology will now provide physicians a new, innovative and non-invasive approach for patients seeking a non-surgical option to improve the appearance of cellulite. This latest clearance also marks the next step in the planned commercialization of our RAP technology, and we look forward to introducing this new approach to treating cellulite to physicians in the months to come."
The company's technology harnesses the power of sound for the treatment of cellulite. The unique, rapid-pulsed technology safely and comfortably breaks apart the fibrous septa bands beneath the skin that cause cellulite to deliver efficacious results in just one, 40–60-minute treatment.
In the clinical trials submitted to the FDA as part of the 510(k) application that was cleared, patient results were generated by a single, non-invasive treatment that required no anesthesia, caused no unexpected or serious adverse events, received strong patient satisfaction ratings and was well tolerated by the trial subjects, with an average pain score of 2.4 out of 10. The RAP device induces mechanical disruption in fibrous structures, such as the septae contributing to dimples in cellulite, that results in release of the dimples and general smoothing of the skin.
"Until now, patients have had limited options to effectively improve the appearance of cellulite other than cutting into the skin or less invasive procedures that can have low patient satisfaction. The clearance of this technology for cellulite fills this gap in available treatments and is an exciting development for healthcare professionals who are committed to providing patients effective procedures without any downtime," said Elizabeth Tanzi, director at Capital Laser & Skin Care, Chevy Chase, Md., and a member of Soliton's Scientific Advisory Board. "This non-invasive technology gives us a new cellulite reduction option to help address this unmet need for our patients."
Leveraging its proprietary technology, the Soliton RAP device is designed to safely deliver rapid, high-pressure acoustic shockwaves at a rate of up to 100 pulses per second through a replaceable treatment cartridge. This results in physical effects on targeted structures and tissues, such as fibrous septa.
Importantly, the negative pressure component of each acoustic pulse is attenuated so therapy can be provided without creating cavitation or heating that could result in surrounding tissue damage. As a result, the RAP technology can provide meaningful results within a single, comfortable treatment that has minimal side effects and no downtime.
Soliton RAP technology also received 510(k) clearance from the FDA for the removal of tattoos in mid 2019.
The company plans to begin selling the device for both tattoo removal and cellulite treatment in the first half of 2021.
The U.S. Food and Drug Administration (FDA) recently cleared Soliton Inc.'s Rapid Acoustic Pulse (RAP) technology for the short-term improvement in the appearance of cellulite.
"We're thrilled to receive this latest clearance for our RAP technology," said Brad Hauser, president and CEO of Soliton. "Our technology will now provide physicians a new, innovative and non-invasive approach for patients seeking a non-surgical option to improve the appearance of cellulite. This latest clearance also marks the next step in the planned commercialization of our RAP technology, and we look forward to introducing this new approach to treating cellulite to physicians in the months to come."
The company's technology harnesses the power of sound for the treatment of cellulite. The unique, rapid-pulsed technology safely and comfortably breaks apart the fibrous septa bands beneath the skin that cause cellulite to deliver efficacious results in just one, 40–60-minute treatment.
In the clinical trials submitted to the FDA as part of the 510(k) application that was cleared, patient results were generated by a single, non-invasive treatment that required no anesthesia, caused no unexpected or serious adverse events, received strong patient satisfaction ratings and was well tolerated by the trial subjects, with an average pain score of 2.4 out of 10. The RAP device induces mechanical disruption in fibrous structures, such as the septae contributing to dimples in cellulite, that results in release of the dimples and general smoothing of the skin.
"Until now, patients have had limited options to effectively improve the appearance of cellulite other than cutting into the skin or less invasive procedures that can have low patient satisfaction. The clearance of this technology for cellulite fills this gap in available treatments and is an exciting development for healthcare professionals who are committed to providing patients effective procedures without any downtime," said Elizabeth Tanzi, director at Capital Laser & Skin Care, Chevy Chase, Md., and a member of Soliton's Scientific Advisory Board. "This non-invasive technology gives us a new cellulite reduction option to help address this unmet need for our patients."
Leveraging its proprietary technology, the Soliton RAP device is designed to safely deliver rapid, high-pressure acoustic shockwaves at a rate of up to 100 pulses per second through a replaceable treatment cartridge. This results in physical effects on targeted structures and tissues, such as fibrous septa.
Importantly, the negative pressure component of each acoustic pulse is attenuated so therapy can be provided without creating cavitation or heating that could result in surrounding tissue damage. As a result, the RAP technology can provide meaningful results within a single, comfortable treatment that has minimal side effects and no downtime.
Soliton RAP technology also received 510(k) clearance from the FDA for the removal of tattoos in mid 2019.
The company plans to begin selling the device for both tattoo removal and cellulite treatment in the first half of 2021.
