510(k) K132874

LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM by Nucletron B.V. — Product Code JAQ

K132874 is an FDA 510(k) premarket notification submitted by Nucletron B.V. for the device "LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM". The FDA issued a decision of Substantially Equivalent on February 21, 2014. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron B.V. has at least 10 other 510(k) clearances on record.