510(k) Report

Devices descending from K121091

12 later devices reach Catalys Precision Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150323FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering201521
+1K141079Optimedica Catalys Precision Laser SystemOptimedica Corporation201483
+2K213559FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering20221—
+2K161455Catalys Precision Laser SystemOptimedica Corporation20167—
+3K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.20230—
+3K170322Catalys Precision Laser SystemAbbott Medical Optics, Inc.201761
+4K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC201751
+5K182083Catalys Precision Laser SystemAmo Manufacturing USA, LLC20184—
+6K200056Catalys Precision Laser SystemAmo Manufacturng USA, LLC20203—
+7K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC20230—
+7K210701CATALYS Precision Laser SystemAmo Manufacturing USA, LLC20211—
+8K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC20220—