1125 XSB XENON FIBER-OPTIC LIGHT SOURCE

1125 XSB XENON FIBER-OPTIC LIGHT SOURCE is an FDA 510(k)-cleared medical device (K052979) manufactured by Isolux, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 2005. Regulation: 8.