510(k) Report

Devices descending from K211269

7 later devices reach Visualase MRI-Guided Laser Ablation System (SW 3.4) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+1K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+1K231061NeuroBlate SystemMonteris Medical,20236—
+2K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+3K262315NeuroBlate SystemMonteris Medical20260—
+3K260976NeuroBlate SystemMonteris Medical20261—
+3K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—