510(k) K212039

CLAREON MONARCH IV IOL Delivery System by Alcon Laboratories, Inc. — Product Code MSS

K212039 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "CLAREON MONARCH IV IOL Delivery System". The FDA issued a decision of Substantially Equivalent on August 23, 2021. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.