510(k) K062895

XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII by Dutch Ophthalmic Research Center International BV — Product Code MPA

K062895 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic Research Center International BV for the device "XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII". The FDA issued a decision of Substantially Equivalent on October 13, 2006. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Dutch Ophthalmic Research Center International BV has at least 3 other 510(k) clearances on record.