Soliton, Inc. announced that the U.S. Food and Drug Administration (‘FDA’) has accepted its special 510(k) application previously submitted on March 31, 2021 for modifications to RESONIC™ device planned for commercial launch as complete. The company expects to hear if the FDA has cleared its special 510(k) application in the next 15-20 days unless the process takes slightly longer than normal given the COVID-related workload inside the FDA. The changes submitted in the special 510(k) application include the development of an autoloading cartridge and an improved user interface. These modifications are geared towards providing for a more seamless user experience. In addition, Soliton achieved several manufacturing milestones in anticipation for its planned second quarter of 2021 initial launch of RESONIC for both cellulite and tattoo removal indications. The Company successfully completed all required safety testing including Quality System/Current Good Manufacturing Practice regulations for medical devices (21 CFR Part 820) inspection from the FDA. Additionally, the Company expanded its sales team through the hiring of 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.