510(k) K132475

FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM by Fluoptics — Product Code OWN

K132475 is an FDA 510(k) premarket notification submitted by Fluoptics for the device "FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM". The FDA issued a decision of Substantially Equivalent on May 7, 2014. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Fluoptics has at least 3 other 510(k) clearances on record.