510(k) K052979

1125 XSB XENON FIBER-OPTIC LIGHT SOURCE by Isolux, LLC — Product Code HBI

K052979 is an FDA 510(k) premarket notification submitted by Isolux, LLC for the device "1125 XSB XENON FIBER-OPTIC LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on October 31, 2005. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Isolux, LLC has at least 2 other 510(k) clearances on record.