Medical device company Soliton Inc. (NASDAQ: SOLY) has received FDA 510(k) approval for its acoustic wave device for dermal tattoo clearing.
Soliton shares were ripping higher by 130.37 percent at $13.20 at the time of publication Tuesday.
Soliton has developed a breakthrough science for tattoo removal using rapid acoustic pulse, or RAP, technology. The FDA approved the RAP tattoo removal device, and the application will now move to a substantive review.
The device is indicated as an accessory to the 1064 nm Q-Switched (pulsed) laser for black ink tattoo removal on the arms, legs and torso in Fitzpatrick skin type I-III individuals, according to Soliton.
Why It's Important
Clinical trials have demonstrated that using the company's RAP device in conjunction with a Q-Switched laser allows for multiple passes of laser treatment in a single treatment session.
In clinical trials using the RAP device in conjunction with a Q-Switched laser, patients experienced 75-100-percent removal of their tattoos in just three office visits, the company said.
"Having found that our submission contained all the necessary elements and information, we look forward to the substantive review and FDA clearance of the RAP device," Soliton CEO Christopher Capelli said in a statement.
The tattoo removal market is estimated to be approximately $4.8 billion in size by 2023, Capelli said.
"Because our technology relies upon replaceable cartridges for each treatment, we believe our business model will benefit from recurring revenue, allowing Soliton to share in the volume growth in the aesthetic category expected in the coming years."
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