510(k) Report

Devices descending from K040837

25 later devices reach Multiject Injector and Microglide Cartridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103495Asico Softip Injector SystemAsico, LLC20117—
+1K070669Iol Injector SetMedicel AG2007191
+1K060533Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc.200611—
+1K050638Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular LensesLenstec, Inc.200512—
+2K142056Lioli Iol Delivery SystemAst Products, Inc.20156—
+2K092023Naviject SUB2-1P, Model: LP604430Medicel AG200918—
+2K063802Lenstec LC Injection SystemLenstec, Inc.200710—
+3K172228pioli IOL Delivery SystemAst Products, Inc.20175—
+3K122848Lenstec LC Injection SystemLenstec, Inc.20131—
+3K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc.201212—
+3K101134Visian Nanopoint 2.0 Injector Model LP604430Medicel AG20101—
+4K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG20250—
+4K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated20240—
+4K231106Accuject Refra Injector AR2900Medicel AG20230—
+4K231838RxSight® Insertion Device (63002)Rxsight, Inc.20231—
+4K192005Bausch + Lomb PreVue Inserter for enVista PreloadedBausch & Lomb, Inc.20191—
+4K181401RxSight Insertion DeviceRxsight, Inc.20184—
+4K161776Lenstec LC Injection systemLenstec, Inc.20160—
+4K131958Bausch & Lomb Injector SystemBausch & Lomb20149—
+4K133146Bausch + Lumb, VIS100 Injector SystemBausch & Lomb20140—
+5K261174RxSight® Insertion DeviceRxsight, Inc.20260—
+5K192926RxSight Insertion DeviceRxsight, Inc.20203—
+5K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc.,20160—
+5K151102Bausch + Lomb Injector SystemBausch & Lomb, Inc.20155—
+6K231466RxSight Insertion DeviceRxsight, Inc.20232—