510(k) K173371

VisuMax Femtosecond Laser by Carl Zeiss Meditec, Inc. — Product Code HNO

K173371 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, Inc. for the device "VisuMax Femtosecond Laser". The FDA issued a decision of Substantially Equivalent on April 13, 2018. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Carl Zeiss Meditec, Inc. has at least 10 other 510(k) clearances on record.