Medical device company Soliton Inc (Nasdaq:SOLY) said on Tuesday that it has completed the human trials of its proprietary Rapid Acoustic Pulse (RAP) technology to accelerate tattoo fading in support of US FDA 510(k) submission.
In connection with the US FDA 510(k) submission, the company has launched three rounds of human trials to study the use of the RAP device to accelerate tattoo fading.
According to the company, its first planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of unwanted tattoos (RAP device).
The human trials provided evidence that the combination treatment of the RAP device and a laser outperformed a laser alone, showing an average of 80% fading after only two visits vs 44% fading for the laser alone. After three Soliton Multi-Pass treatments, 100% of the treated tattoos had a 'Complete' (76-100% faded) response. In comparison, only 17% of the tattoos treated with the Laser Only had a 'Complete' response, the company's CEO Dr Chris Capelli stated.
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