510(k) Report

Devices descending from K053087

33 later devices reach Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling… through their predicates, nearest generation first.

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