510(k) Report

Devices descending from K010041

39 later devices reach SLT Diffuser Fiber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053087Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter SystemBiotex, Inc.2006335
+1K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+1K022655Trimedyne Side Firing Needle with Vent SheathTrimedyne, Inc.20023—
+2K230460Laser Thermal Therapy KitElesta S.P.A20231—
+2K202953Aurolase Therapy, Laser Delivery Device (LDD)Nanospectra Biosciences, Inc.20220—
+2K151569Tranberg CLS Laser FiberClinical Laserthermia Systems, AB201621
+2K071328Visualase Thermal Therapy SystemBiotex, Inc.2007261
+2K050412VapormaxTrimedyne, Inc.20052—
+3K260632Laser Thermal Therapy KitElesta S.P.A20260—
+3K163103Tranberg CLS Diffusor Laser FiberClinical Laserthermia Systems, AB201711
+3K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+3K081656Visualase Thermal Therapy SystemBiotex, Inc.2008101
+3K053457Vapormax IITrimedyne, Inc.20051—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+4K201466Tranberg CLS Laser ApplicatorClinical Laserthermia Systems, AB20210—
+4K181859Visualase Thermal Therapy SystemMedtronic Navigation, Inc.201991
+4K182036NeuroBlate SystemMonteris Medical,201811—
+4K172881NeuroBlate SystemMonteris Medical,201713—
+4K120561Neuroblate SystemMonteris Medical, Inc.2013211
+5K231061NeuroBlate SystemMonteris Medical,20236—
+5K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB20227—
+5K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+5K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+5K193375NeuroBlate SystemMonteris Medical,202010—
+5K173305NeuroBlate SystemMonteris Medical,201712—
+5K170724NeuroBlate SystemMonteris Medical,201715—
+5K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+5K141983Neuroblate SystemMonteris Medical Corp.2014182
+5K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+5K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+6K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+6K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+6K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+6K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+6K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+6K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+6K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+7K262315NeuroBlate SystemMonteris Medical20260—
+7K260976NeuroBlate SystemMonteris Medical20261—