510(k) K211269

Visualase MRI-Guided Laser Ablation System (SW 3.4) by Medtronic Navigation, Inc. — Product Code ONO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 7, 2022
Date Received: April 27, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Neurosurgical Laser With Mr Thermography
Device Class: Class II
Regulation Number: 878.4810
Review Panel: NE
Submission Type

Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.

Other clearances by Medtronic Navigation, Inc.

K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Appli (March 13, 2026)
K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application (February 12, 2026)
K251282 — StealthStation S8 Spine Software (October 17, 2025)
K242464 — Stealth Spine Clamps; ModuLeX Shank Mounts (June 5, 2025)
K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422) (May 29, 2025)
K240465 — O-arm O2 Imaging System (June 21, 2024)
K231976 — StealthStation Cranial Software, v3.1.5 (9735585) (October 19, 2023)
K221087 — Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 (June 10, 2022)
K212397 — StealthStation S8 Cranial v2.0 (December 22, 2021)
K211442 — StealthStation Spinous Process Clamps (July 8, 2021)

Other clearances for product code ONO

K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Appli (March 13, 2026)
K251298 — Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (September 4, 2025)
K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422) (May 29, 2025)
K240877 — Monteris Medical NeuroBlate System (June 4, 2024)
K214125 — TRANBERG Thermoguide Therapy System (September 22, 2022)