510(k) K921646

NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON by Nextec Corp. — Product Code FST

K921646 is an FDA 510(k) premarket notification submitted by Nextec Corp. for the device "NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON". The FDA issued a decision of Substantially Equivalent on May 13, 1992. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Nextec Corp. has at least 2 other 510(k) clearances on record.