510(k) Report

Devices descending from K961310

78 later devices reach Storz Premiere II Microsurgical System (CX Series) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101325Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc.2010141
+1K081877Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV20098—
+1K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc.2009224
+1K063583Alcon Vision SystemAlcon20083611
+1K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc.20062412
+1K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc.2006321
+1K021566InfinitiAlcon Laboratories, Inc.2002503
+1K983797D.O.R.C. Harmony Total Vitrectomy SystemDutch Ophthalmic USA, Inc.19990—
+1K980488Storz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co.199814
+1K972664Storz Millennium Viscous Fluid SystemStorz Instrument Co.199714—
+1K964743Storz E8010 Ergotec/Premiere AdaptorStorz Instrument Co.19970—
+2K160236Dual Pump PackAbbott Medical Optics, Inc.201611
+2K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155—
+2K141065Constellation Vision SystemAlcon Research, Ltd.201426
+2K133562Catarhex 3Oertli Instrumente AG20141—
+2K133486Stellaris PC Vision Enhancement SystemBausch & Lomb201473
+2K133242Stellaris Vision Enhancement SystemBausch & Lomb20144—
+2K121555Centurion Vision SystemAlcon Laboratories, Inc.201264
+2K120912Infiniti (R) Vision SystemAlcon Manufacturing, Ltd.201231
+2K111446Sovereign Compact Phacoemulsification SystemAbbott Medical Optics, Inc.201141
+2K112425Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd.20118—
+2K11095127+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…Alcon Research, Ltd.201131
+2K111697Amo Whitestar Signature Phacoemulsification SystemAbbott Medical Optics, Inc.20112—
+2K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc.201112—
+2K101285Constellation Vision SystemAlcon Manufacturing, Ltd.2010174
+2K093305Enhanced Ultra Vit ProbeAlcon Research, Ltd.201018—
+2K093210Aqualase Capsule Wash TipAlcon Manufacturing, Ltd.20109—
+2K091777Alcon UltrachopperAlcon Research, Ltd.200920—
+2K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd.200922—
+2K031404Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company20030—
+2K993039Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc.200013—
+3K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…Alcon Laboratories, Inc.202402
+3K233398Faros Surgical SystemOertli Instrumente AG20240—
+3K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc.202402
+3K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+3K213173TrabEx ProMicrosurgical Technologies, Inc.20220—
+3K212241Quatera 700Carl Zeiss Meditec, AG20221—
+3K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced…Johnson & Johnson Surgical Vision, Inc.202103
+3K193376Visalis V500, Visalis S500Carl Zeiss Meditec, AG20200—
+3K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+3K170052Stellaris Elite vision enhancement systemBausch+Lomb20171—
+3K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd.20173—
+3K162342Stellaris Elite Vision Enhancement SystemBausch+Lomb2017113
+3K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…Alcon Research, Ltd.20171—
+3K151636AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance…Abbott Medical Optics, Inc.20151—
+3K140615Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20143—
+3K133115Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use…Abbott Medical Optics, Inc.201431
+3K120214TBDLensar, Inc.20126—
+3K112098TBDLensar, Inc.20117—
+3K050716Iscience Surgical ViscoinjectorIscience Surgical Corporation200511—
+4K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack (s)…Bausch and Lomb20260—
+4K250501System SophiThis AG20250—
+4K232084Stellaris Elite vision enhancement systemBausch and Lomb20240—
+4K233902Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc.20240—
+4K230858Quatera 700Carl Zeiss Meditec, AG20230—
+4K220030Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC20220—
+4K191650LEGION SystemAlcon Research, LLC201901
+4K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc.20170—
+4K151783COMPACT INTUITIV Multiple-Use PackAbbott Medical Optics, Inc.20150—
+4K151161VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20152—
+4K132494Viscoelastic InjectorSight Sciences, Inc.201310—
+4K123859TBDLensar, Inc.20134—
+4K122829Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc.20125—
+5K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20171—
+5K143010LENSAR Laser System - fs 3DLensar, Inc.20153—
+5K143205Viscoelastic InjectorSight Sciences, Inc.20149—
+6K200724VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20200—
+6K171905VISCO 360 Viscosurgical SystemSight Sciences, Inc.20178—
+6K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20171—
+6K152453LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20152—
+7K212797iPrime Viscodelivery SystemGlaukos20220—
+7K173332OMNI Surgical SystemSight Sciences, Inc.20176—
+8K243503VIA360™ Surgical SystemNew World Medical, Inc.20250—
+8K211680Streamline Surgical SystemNew World Medical, Inc.20210—
+8K202678OMNI Surgical SystemSight Sciences, Inc.20212—
+8K201953OMNI PLUS Surgical SystemSight Sciences, Inc.20200—
+9K232214OMNI Surgical SystemSight Sciences, Inc.20231—
+10K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc.20260—