FLEXISCOPE, MODELS 50MH AND 50 MHC

FLEXISCOPE, MODELS 50MH AND 50 MHC is an FDA 510(k)-cleared medical device (K053412) manufactured by Schoelly Imaging, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 22, 2006. Regulation: 8.