Visualase V2 MRI-guided Laser Ablation System (9736422)— 510(k) K250307

Name: FDA 510(k) clearance K250307
Creator: U.S. Food and Drug Administration
Published: 2025-05-29

Substantially Equivalent

Medtronic Navigation

FDA 510(k) clearance K250307 for Visualase V2 MRI-guided Laser Ablation System (9736422), Substantially Equivalent on 2025-05-29. Applicant: Medtronic Navigation. Device class: 2.

Clearance details

Applicant: Medtronic Navigation
Product code: Code ONO
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-02-03
Decision date: 2025-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, US

Download summary PDF View on FDA.gov ↗

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K262315 — NeuroBlate System2026-09-03
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K251298 — Mobile Laser Unit (1001-N2) +3 more2025-09-04
K240877 — Monteris Medical NeuroBlate System2024-06-04

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Data sourced from openFDA. This site is unofficial and independent of the FDA.