Soliton, a medical device company has received the US Food & Drug Administration (FDA) clearance to market its Rapid Acoustic Pulse (RAP) device for tattoo removal.
Image: The new RAP Device safely converts 3,000volts at 3,000amps into well controlled acoustic shockwaves. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.
Soliton has designed the device that is designated as an accessory to the 1064nm Q-Switched laser for black ink tattoo removal on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals.
The company holds a novel platform technology licensed from the University of Texas on behalf of the MD Anderson Cancer Center.
Soliton has taken more than 5 years and spent more than £20m in research and development for creating the advanced shockwave device, which also includes collaborations with a various experts, including engineers working on Space Shuttle ignition system, scientists in plasma physics and physicists in acoustic engineering.
The company said that the new RAP Device safely converts 3,000volts at 3,000amps into well controlled acoustic shockwaves at a rate of up to 100 pulses per second through a replaceable treatment cartridge.
Along with a significant amount of power being converted into an acoustic pulse, the device delivers it in extremely brief time, with both a very short rise time and a short fall time.
The device thus creates a microscopic mechanical disruption at the targeted cellular level structures and vacuoles, and the negative pressure component associated with the acoustic pulse is reduced, to avoid cavitation, heat or collateral tissue damage that results in the pain sensation for patient.
Soliton president CEO and co-founder Dr. Chris Capelli said: “Receiving clearance from the FDA, while in line with our expectations, is nonetheless gratifying and validating, representing a bedrock for the commercialization plan of our RAP technology.
“This clearance to market allows us to begin the transition from R&D to expanded product development and commercialization within the tattoo removal segment.”
Soliton said that its RAP technology is capable of providing significant results with little scope for bruising or other treatment related downtime. The device currently covers 8 patent families with 68 patents issued or pending.
Considering the estimated annual growth in tattoo removal industry, the company is planning to advance the commercialisation of the device, while the revenue generation is expected in the first half of 2020.https://www.prnewswire.com/news-releases/soliton-receives-fda-510k-clearance-of-its-acoustic-shockwave-rap-device-300857383.html