
Infinitech, Inc.
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INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM is an FDA 510(k)-cleared medical device (K951627) manufactured by Infinitech, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 1995. Regulation: 8.