510(k) Report

Devices descending from K081656

10 later devices reach Visualase Thermal Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181859Visualase Thermal Therapy SystemMedtronic Navigation, Inc.201991
+2K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB20227—
+2K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+3K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+3K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+3K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+3K231061NeuroBlate SystemMonteris Medical,20236—
+4K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+5K262315NeuroBlate SystemMonteris Medical20260—
+5K260976NeuroBlate SystemMonteris Medical20261—