510(k) K052814

LUMINA 1600, 3300 AND 6600 SYSTEMS by Usa Laser Biotech, Inc. — Product Code ILY

K052814 is an FDA 510(k) premarket notification submitted by Usa Laser Biotech, Inc. for the device "LUMINA 1600, 3300 AND 6600 SYSTEMS". The FDA issued a decision of Substantially Equivalent on November 30, 2005. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Usa Laser Biotech, Inc. has at least 5 other 510(k) clearances on record.