510(k) K231106

Accuject Refra Injector AR2900 by Medicel AG — Product Code MSS

K231106 is an FDA 510(k) premarket notification submitted by Medicel AG for the device "Accuject Refra Injector AR2900". The FDA issued a decision of Substantially Equivalent on September 19, 2023. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Medicel AG has at least 5 other 510(k) clearances on record.