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Soliton Provides Special 510(k) and Commercialization Update
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HOUSTON, April 15, 2021 /PRNewswire/ Soliton, Inc., (Nasdaq: SOLY) ( Soliton or the Company ), a medical device company with a novel and proprietary platform technology, today 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.