510(k) Report

Devices descending from K930320

32 later devices reach Amo Phacoflex Inserter, Foldable Iol Insert Instr through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961242Amo Phacoflex II Intersection SystemAllergan, Inc.199631—
+2K081545One Series Ultra Cartridge, Model 1VIPR30Advanced Medical Optics, Inc.20081—
+2K040837Multiject Injector and Microglide CartridgeMedicel AG200425—
+2K023737InjectorAnton Meyer & Co., Ltd.20031—
+2K022723Mastel 1 Folder Implantation SystemMastel Precision, Inc.20020—
+3K143434One Series ULTRA Cartridge, The UNFOLDER Platinum 1 SeriesAbbott Medical Optics, Inc.20150—
+3K103495Asico Softip Injector SystemAsico, LLC20117—
+3K073010Royale AE 9036 LSP InjectorAsico, LLC20070—
+3K070669Iol Injector SetMedicel AG2007191
+3K060533Lenstec Intraocular Lens (Iol) Injection SystemLenstec, Inc.200611—
+3K050638Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular LensesLenstec, Inc.200512—
+4K142056Lioli Iol Delivery SystemAst Products, Inc.20156—
+4K092023Naviject SUB2-1P, Model: LP604430Medicel AG200918—
+4K063802Lenstec LC Injection SystemLenstec, Inc.200710—
+5K172228pioli IOL Delivery SystemAst Products, Inc.20175—
+5K122848Lenstec LC Injection SystemLenstec, Inc.20131—
+5K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc.201212—
+5K101134Visian Nanopoint 2.0 Injector Model LP604430Medicel AG20101—
+6K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG20250—
+6K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated20240—
+6K231106Accuject Refra Injector AR2900Medicel AG20230—
+6K231838RxSight® Insertion Device (63002)Rxsight, Inc.20231—
+6K192005Bausch + Lomb PreVue Inserter for enVista PreloadedBausch & Lomb, Inc.20191—
+6K181401RxSight Insertion DeviceRxsight, Inc.20184—
+6K161776Lenstec LC Injection systemLenstec, Inc.20160—
+6K131958Bausch & Lomb Injector SystemBausch & Lomb20149—
+6K133146Bausch + Lumb, VIS100 Injector SystemBausch & Lomb20140—
+7K261174RxSight® Insertion DeviceRxsight, Inc.20260—
+7K192926RxSight Insertion DeviceRxsight, Inc.20203—
+7K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc.,20160—
+7K151102Bausch + Lomb Injector SystemBausch & Lomb, Inc.20155—
+8K231466RxSight Insertion DeviceRxsight, Inc.20232—