510(k) K133425

SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT by Engineered Medical Solutions Co., LLC — Product Code FTD

K133425 is an FDA 510(k) premarket notification submitted by Engineered Medical Solutions Co., LLC for the device "SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT". The FDA issued a decision of Substantially Equivalent on December 5, 2013. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Engineered Medical Solutions Co., LLC has at least 1 other 510(k) clearance on record.