510(k) K984443

ORBSCAN by Technolas Perfect Vision GmbH — Product Code MXK

K984443 is an FDA 510(k) premarket notification submitted by Technolas Perfect Vision GmbH for the device "ORBSCAN". The FDA issued a decision of Substantially Equivalent on March 5, 1999. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850. Technolas Perfect Vision GmbH has at least 9 other 510(k) clearances on record.