510(k) K122593

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 by Optim, LLC — Product Code FEH

K122593 is an FDA 510(k) premarket notification submitted by Optim, LLC for the device "PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2". The FDA issued a decision of Substantially Equivalent on September 13, 2012. The device falls under product code FEH (Electrode, Flexible Suction Coagulator), a Class II device regulated under 21 CFR 876.4300. Optim, LLC has at least 5 other 510(k) clearances on record.