
Sharplan Lasers, Inc.
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I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA is an FDA 510(k)-cleared medical device (K934097) manufactured by Sharplan Lasers, 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 February 6, 1994. Regulation: 8.