SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM

SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K945796) manufactured by Sharplan Lasers, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 1995. Regulation: 8.