510(k) K100378

1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 by Daavlin Distributing Co. — Product Code FTC

K100378 is an FDA 510(k) premarket notification submitted by Daavlin Distributing Co. for the device "1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4". The FDA issued a decision of Substantially Equivalent on April 28, 2010. 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.