510(k) K200542

Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head by Olympus Medical Systems Corp. — Product Code OWN

K200542 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head". The FDA issued a decision of Substantially Equivalent on Jul 17, 2020. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corp. has 103 other 510(k) clearances on record.