510(k) K111172

4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES by Daavlin Distributing Co. — Product Code FTC

K111172 is an FDA 510(k) premarket notification submitted by Daavlin Distributing Co. for the device "4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES". The FDA issued a decision of Substantially Equivalent on August 29, 2011. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Daavlin Distributing Co. has at least 10 other 510(k) clearances on record.