510(k) K052935

HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) by Heidelberg Engineering — Product Code MXK

K052935 is an FDA 510(k) premarket notification submitted by Heidelberg Engineering for the device "HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)". The FDA issued a decision of Substantially Equivalent on January 13, 2006. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850. Heidelberg Engineering has at least 10 other 510(k) clearances on record.