510(k) K022104

DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ by Daavlin Distributing Co. — Product Code FTC

K022104 is an FDA 510(k) premarket notification submitted by Daavlin Distributing Co. for the device "DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ". The FDA issued a decision of Substantially Equivalent on September 10, 2002. 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.