510(k) K192926

RxSight Insertion Device by Rxsight, Inc. — Product Code MSS

K192926 is an FDA 510(k) premarket notification submitted by Rxsight, Inc. for the device "RxSight Insertion Device". The FDA issued a decision of Substantially Equivalent on January 17, 2020. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Rxsight, Inc. has at least 5 other 510(k) clearances on record.