510(k) Report

Devices descending from K935342

77 later devices reach SCMD Keratome through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974243Keratome SystemInsight Technologies Instruments, LLC19980—
+1K970377Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)Plancon Instruments199776—
+2K032836M3 MicrokeratomeMoria SA20040—
+2K030891Surgistar Microkeratome Blade, Model NO. 2400-LSKSurgistar, Inc.20030—
+2K992687Millenium Microkeratome, Model Imd-001Industrial & Medical Design, Inc.19990—
+2K981742One UP Disposable Keratome HeadMoria, Inc.19983—
+2K980924Plancon Microlamellar Keratome EvolutionPlancon Instruments199866—
+2K973294Innovatome MicrokeratomeInnovative Optics, Inc.19975—
+3K032910Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG200458—
+3K040297Oneuse- Plus MicrokeratomeMoria SA20042—
+3K011833MB 103 Millennium BladesMillennium Biomedical, Inc.20020—
+3K990900Microkeratome, Model MK-2000Nidek, Inc.19992—
+3K983317Barron Microkeratome System, Model B2000Barron Precision Instruments, LLC19981—
+3K981741Carriazo Barraquer MicrokeratomeMoria, Inc.199863—
+4K101006Wavelight FS200 Laser System Model: FS200Alcon Research, Ltd.2010211
+4K082043Carriazo-Pendular MicrokeratomeSchwind Eye-Tech-Solutions GmbH & Co. KG20080—
+4K073404Ifs Laser SystemIntra Lase Corp.200856—
+4K043183EPI-KMoria SA20051—
+4K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc.20030—
+4K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc.20020—
+4K991124Visijet Hydrokeratome, Model 50Visijet, Inc.20000—
+5K172994EPI K ConsoleMoria SA20170—
+5K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc.20148—
+5K120732Lenssx Laser SystemAlcon Lensx, Inc.2012121
+5K121031Wavelight FS200 Patient Interface 1505Alcon Research, Ltd.201210—
+5K113151Ifs Laser SystemAbbott Medical Optics, Inc.201219—
+5K100253Visumax Laser KeratomeCarl Zeiss Meditec, AG2010141
+5K082947Lensx 550 Laser SystemLensx Lasers, Inc.200951—
+6K190392WaveLight FS200 Patient InterfaceAlcon Laboratories, Inc.20190—
+6K182795LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20181—
+6K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.20180—
+6K173660LenSx Laser SystemAlcon Laboratories, Inc.20182—
+6K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20183—
+6K161288LenSX Laser SystemAlcon Laboratories, Inc.20164—
+6K141852Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC20155—
+6K140615Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20143—
+6K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20145—
+6K122386Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20136—
+6K123120Lensx Laser SystemAlcon Lensx, Inc.20125—
+6K120426Victus Laser PlatformTechnolas Perfect Vision GmbH20127—
+6K110427Femtec Laser System for CapsulotomyTechnolas Perfect Vision GmbH20118—
+6K112098TBDLensar, Inc.20117—
+6K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc.201112—
+6K101626Lensx Laser SystemLensx Lasers, Inc.201030—
+6K090633Lensar Laser SystemLensar, Inc.201018—
+6K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc.201047—
+6K092647Lensx 550 Laser SystemLensx Lasers, Inc.200931—
+7K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.20251—
+7K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.20230—
+7K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.20220—
+7K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20182—
+7K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc.20170—
+7K163551LenSx Laser SystemAlcon Laboratories, Inc.20173—
+7K151161VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20152—
+7K141379Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20153—
+7K123859TBDLensar, Inc.20134—
+7K122829Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc.20125—
+7K120214TBDLensar, Inc.20126—
+7K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation2011132
+8K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.20250—
+8K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20171—
+8K143010LENSAR Laser System - fs 3DLensar, Inc.20153—
+8K121091Catalys Precision Laser SystemOptimedica Corporation2012122
+9K200724VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20200—
+9K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20171—
+9K150323FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering201521
+9K152453LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20152—
+9K141079Optimedica Catalys Precision Laser SystemOptimedica Corporation201483
+10K213559FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering20221—
+10K161455Catalys Precision Laser SystemOptimedica Corporation20167—
+11K170322Catalys Precision Laser SystemAbbott Medical Optics, Inc.201761
+12K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC201751
+13K182083Catalys Precision Laser SystemAmo Manufacturing USA, LLC20184—
+14K200056Catalys Precision Laser SystemAmo Manufacturng USA, LLC20203—
+15K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC20230—
+15K210701CATALYS Precision Laser SystemAmo Manufacturing USA, LLC20211—
+16K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC20220—