Treatment of erectile dysfunction in adult males aged 22 years and over . U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.0 6 . 0 2 Silver Spring, M D 20993 www.fda.gov June 9, 2023 Re: DEN220078 Trade/Device Name: Eroxon Regulation Number: 21 CFR 876.5021 Regulation Name: Non- medicated top ical formula tion for trea tment of erec tile dysfu nction Regulatory Class: II Product Code: QWW Dated: January 4, 2023 Received: March 28, 2023 Dear Ken James: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the Eroxon, an over- the - counter device under 21 CFR Part 801 Subpart C with the following indications for use: Treatment of erectile dysfunction in adult males aged 22 years and over. FDA concludes that this device should be classified into Class II. Th is order, therefor
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