510(k) K261174

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

K261174 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 June 10, 2026. 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.