Soliton has announced that the U.S. Food and Drug Administration (FDA) has accepted its 510(k) application for modifications to the RESONIC device. The company expects to hear if the FDA has cleared its application in the next 15-20 days.
The changes submitted in the special 510(k) application include the development of an autoloading cartridge and an improved user interface.
The RESONIC device features the company's rapid acoustic pulse (RAP) technology and is indicated for both cellulite and tattoo removal.
In anticipation of the commercial launch of the device, Soliton hired two senior practice development managers with previous experience in the aesthetics space. This role will be focused on in-practice execution of the introduction and support of the RESONIC device and RAP technology.
"With the FDA's acceptance of our special 510(k) application for improved commercial use and successful completion of all safety testing, we believe we are well positioned to successfully bring RESONIC to market later this quarter," stated Brad Hauser, president and CEO of Soliton. "We believe our commitment to improving the design and safety of our RAP technology is critical for Soliton's commercial success. We look forward to bringing these improvements to market with the support of our new seasoned practice development managers."
