510(k) Report

Devices descending from K971648

58 later devices reach Sharplan Erbium: Yag Laser (4020) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981438Dornier Medilas EDornier Surgical Products, Inc.199856—
+1K980313Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystalaseSchwartz Electro-Optics, Inc.19980—
+2K052806BuraneWavelight Laser Technologie AG200552—
+2K050317Burane XLWavelight Laser Technologie AG200553—
+2K993146Dornier Scanner HandpieceDornier Surgical Products, Inc.19990—
+2K984349Dornier Medilas RDornier19990—
+3K082947Lensx 550 Laser SystemLensx Lasers, Inc.200951—
+4K110427Femtec Laser System for CapsulotomyTechnolas Perfect Vision GmbH20118—
+4K112098TBDLensar, Inc.20117—
+4K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc.201112—
+4K101626Lensx Laser SystemLensx Lasers, Inc.201030—
+4K090633Lensar Laser SystemLensar, Inc.201018—
+4K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc.201047—
+4K092647Lensx 550 Laser SystemLensx Lasers, Inc.200931—
+5K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc.20170—
+5K161288LenSX Laser SystemAlcon Laboratories, Inc.20164—
+5K140615Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20143—
+5K123859TBDLensar, Inc.20134—
+5K122386Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20136—
+5K122829Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc.20125—
+5K120732Lenssx Laser SystemAlcon Lensx, Inc.2012121
+5K120426Victus Laser PlatformTechnolas Perfect Vision GmbH20127—
+5K120214TBDLensar, Inc.20126—
+5K113151Ifs Laser SystemAbbott Medical Optics, Inc.201219—
+5K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation2011132
+6K163551LenSx Laser SystemAlcon Laboratories, Inc.20173—
+6K151161VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20152—
+6K143010LENSAR Laser System - fs 3DLensar, Inc.20153—
+6K141852Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC20155—
+6K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc.20148—
+6K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20145—
+6K123120Lensx Laser SystemAlcon Lensx, Inc.20125—
+6K121091Catalys Precision Laser SystemOptimedica Corporation2012122
+7K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.20230—
+7K182795LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20181—
+7K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.20180—
+7K173660LenSx Laser SystemAlcon Laboratories, Inc.20182—
+7K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20183—
+7K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20171—
+7K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20171—
+7K150323FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering201521
+7K152453LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20152—
+7K141379Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20153—
+7K141079Optimedica Catalys Precision Laser SystemOptimedica Corporation201483
+8K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.20251—
+8K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.20220—
+8K213559FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering20221—
+8K200724VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20200—
+8K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20182—
+8K161455Catalys Precision Laser SystemOptimedica Corporation20167—
+9K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.20250—
+9K170322Catalys Precision Laser SystemAbbott Medical Optics, Inc.201761
+10K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC201751
+11K182083Catalys Precision Laser SystemAmo Manufacturing USA, LLC20184—
+12K200056Catalys Precision Laser SystemAmo Manufacturng USA, LLC20203—
+13K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC20230—
+13K210701CATALYS Precision Laser SystemAmo Manufacturing USA, LLC20211—
+14K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC20220—