510(k) K153749

3 Series Phototherapy Unit by Daavlin Distributing Company — Product Code FTC

K153749 is an FDA 510(k) premarket notification submitted by Daavlin Distributing Company for the device "3 Series Phototherapy Unit". The FDA issued a decision of Substantially Equivalent on June 30, 2016. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Daavlin Distributing Company has at least 10 other 510(k) clearances on record.