510(k) Report

Devices descending from K946054

62 later devices reach Diplomax through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020527Horizon Phacoemulsification System, Model HZN-2030American Optisurgical, Inc.200211
+1K981116Sovereign Cataract Extraction SystemAllergan, Inc.1998591
+2K151783COMPACT INTUITIV Multiple-Use PackAbbott Medical Optics, Inc.20150—
+2K133115Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use…Abbott Medical Optics, Inc.201431
+2K111446Sovereign Compact Phacoemulsification SystemAbbott Medical Optics, Inc.201141
+2K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd.200922—
+2K080803Visual Phacoemulsification System, Model 551American Optisurgical, Inc.20080—
+2K063583Alcon Vision SystemAlcon20083611
+2K050648Sovereign High Vacuum Pack, Sovereign Compact High Vacuum PackAdvanced Medical Optics, Inc.20050—
+2K033941Millennium Microsurgical System and Peristaltic Phaco PackBausch & Lomb, Inc.200401
+2K031404Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company20030—
+2K021566InfinitiAlcon Laboratories, Inc.2002503
+3K151636AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance…Abbott Medical Optics, Inc.20151—
+3K141065Constellation Vision SystemAlcon Research, Ltd.201426
+3K121555Centurion Vision SystemAlcon Laboratories, Inc.201264
+3K120912Infiniti (R) Vision SystemAlcon Manufacturing, Ltd.201231
+3K112425Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd.20118—
+3K11095127+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…Alcon Research, Ltd.201131
+3K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc.201112—
+3K101285Constellation Vision SystemAlcon Manufacturing, Ltd.2010174
+3K093305Enhanced Ultra Vit ProbeAlcon Research, Ltd.201018—
+3K093210Aqualase Capsule Wash TipAlcon Manufacturing, Ltd.20109—
+3K091777Alcon UltrachopperAlcon Research, Ltd.200920—
+3K081877Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV20098—
+3K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc.20062412
+4K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…Alcon Laboratories, Inc.202402
+4K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc.202402
+4K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced…Johnson & Johnson Surgical Vision, Inc.202103
+4K193376Visalis V500, Visalis S500Carl Zeiss Meditec, AG20200—
+4K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+4K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd.20173—
+4K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…Alcon Research, Ltd.20171—
+4K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155—
+4K133562Catarhex 3Oertli Instrumente AG20141—
+4K140615Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20143—
+4K133242Stellaris Vision Enhancement SystemBausch & Lomb20144—
+4K120214TBDLensar, Inc.20126—
+4K112098TBDLensar, Inc.20117—
+4K101325Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc.2010141
+4K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc.2009224
+5K233398Faros Surgical SystemOertli Instrumente AG20240—
+5K233902Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc.20240—
+5K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+5K220030Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC20220—
+5K212241Quatera 700Carl Zeiss Meditec, AG20221—
+5K191650LEGION SystemAlcon Research, LLC201901
+5K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc.20170—
+5K170052Stellaris Elite vision enhancement systemBausch+Lomb20171—
+5K162342Stellaris Elite Vision Enhancement SystemBausch+Lomb2017113
+5K151161VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20152—
+5K133486Stellaris PC Vision Enhancement SystemBausch & Lomb201473
+5K123859TBDLensar, Inc.20134—
+5K122829Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc.20125—
+6K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack (s)…Bausch and Lomb20260—
+6K250501System SophiThis AG20250—
+6K232084Stellaris Elite vision enhancement systemBausch and Lomb20240—
+6K230858Quatera 700Carl Zeiss Meditec, AG20230—
+6K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20171—
+6K143010LENSAR Laser System - fs 3DLensar, Inc.20153—
+7K200724VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20200—
+7K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20171—
+7K152453LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20152—