510(k) Report

Devices descending from K001157

30 later devices reach Monarch II Iol Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112977Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii Handpiece (H4)Alcon Research, Ltd.201221
+1K063155Monarch Iii Iol Delivery SystemAlcon Manufacturing, Ltd.2007281
+1K022723Mastel 1 Folder Implantation SystemMastel Precision, Inc.20020—
+2K212039CLAREON MONARCH IV IOL Delivery SystemAlcon Laboratories, Inc.20210—
+2K182965BL-Cart IOL Delivery CartridgeAst Products, Inc.20191—
+2K131958Bausch & Lomb Injector SystemBausch & Lomb20149—
+2K123888Z Cartridge Iol Delivery SystemAaren Scientific, Inc.201301
+2K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc.201212—
+2K120912Infiniti (R) Vision SystemAlcon Manufacturing, Ltd.201231
+2K112425Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd.20118—
+2K101774Monarch Iii Iol Delivery System; Monarch Iii P Catridge; Monarch Iii Handpiece (H4)Alcon Manufacturing, Ltd.20110—
+3K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG20250—
+3K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated20240—
+3K200057bioli lOL Delivery SystemAst Products, Inc.20200—
+3K192005Bausch + Lomb PreVue Inserter for enVista PreloadedBausch & Lomb, Inc.20191—
+3K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc.,20160—
+3K151102Bausch + Lomb Injector SystemBausch & Lomb, Inc.20155—
+3K141065Constellation Vision SystemAlcon Research, Ltd.201426
+3K133146Bausch + Lumb, VIS100 Injector SystemBausch & Lomb20140—
+3K121555Centurion Vision SystemAlcon Laboratories, Inc.201264
+4K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc.202402
+4K193376Visalis V500, Visalis S500Carl Zeiss Meditec, AG20200—
+4K181401RxSight Insertion DeviceRxsight, Inc.20184—
+4K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd.20173—
+5K233902Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc.20240—
+5K192926RxSight Insertion DeviceRxsight, Inc.20203—
+5K191650LEGION SystemAlcon Research, LLC201901
+6K231466RxSight Insertion DeviceRxsight, Inc.20232—
+7K261174RxSight® Insertion DeviceRxsight, Inc.20260—
+7K231838RxSight® Insertion Device (63002)Rxsight, Inc.20231—