510(k) Report

Devices descending from K961242

31 later devices reach Amo Phacoflex II Intersection System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081545One Series Ultra Cartridge, Model 1VIPR30Advanced Medical Optics, Inc.20081—
+1K040837Multiject Injector and Microglide CartridgeMedicel AG200425—
+1K023737InjectorAnton Meyer & Co., Ltd.20031—
+1K022723Mastel 1 Folder Implantation SystemMastel Precision, Inc.20020—
+2K143434One Series ULTRA Cartridge, The UNFOLDER Platinum 1 SeriesAbbott Medical Optics, Inc.20150—
+2K103495Asico Softip Injector SystemAsico, LLC20117—
+2K073010Royale AE 9036 LSP InjectorAsico, LLC20070—
+2K070669Iol Injector SetMedicel AG2007191
+2K060533Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc.200611—
+2K050638Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular LensesLenstec, Inc.200512—
+3K142056Lioli Iol Delivery SystemAst Products, Inc.20156—
+3K092023Naviject SUB2-1P, Model: LP604430Medicel AG200918—
+3K063802Lenstec LC Injection SystemLenstec, Inc.200710—
+4K172228pioli IOL Delivery SystemAst Products, Inc.20175—
+4K122848Lenstec LC Injection SystemLenstec, Inc.20131—
+4K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc.201212—
+4K101134Visian Nanopoint 2.0 Injector Model LP604430Medicel AG20101—
+5K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG20250—
+5K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated20240—
+5K231106Accuject Refra Injector AR2900Medicel AG20230—
+5K231838RxSight® Insertion Device (63002)Rxsight, Inc.20231—
+5K192005Bausch + Lomb PreVue Inserter for enVista PreloadedBausch & Lomb, Inc.20191—
+5K181401RxSight Insertion DeviceRxsight, Inc.20184—
+5K161776Lenstec LC Injection systemLenstec, Inc.20160—
+5K131958Bausch & Lomb Injector SystemBausch & Lomb20149—
+5K133146Bausch + Lumb, VIS100 Injector SystemBausch & Lomb20140—
+6K261174RxSight® Insertion DeviceRxsight, Inc.20260—
+6K192926RxSight Insertion DeviceRxsight, Inc.20203—
+6K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc.,20160—
+6K151102Bausch + Lomb Injector SystemBausch & Lomb, Inc.20155—
+7K231466RxSight Insertion DeviceRxsight, Inc.20232—