510(k) K040662

VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS by Chattanooga Group — Product Code ILY

K040662 is an FDA 510(k) premarket notification submitted by Chattanooga Group for the device "VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS". The FDA issued a decision of Substantially Equivalent on September 8, 2004. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Chattanooga Group has at least 10 other 510(k) clearances on record.