510(k) K120820

GIRAFFE BLUE SPOT PT LITE by Lumitex, Inc. — Product Code LBI

K120820 is an FDA 510(k) premarket notification submitted by Lumitex, Inc. for the device "GIRAFFE BLUE SPOT PT LITE". The FDA issued a decision of Substantially Equivalent on June 8, 2012. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Lumitex, Inc. has at least 2 other 510(k) clearances on record.