510(k) K250307

Visualase V2 MRI-guided Laser Ablation System (9736422) by Medtronic Navigation — Product Code ONO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 29, 2025
Date Received: February 3, 2025
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.

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Other clearances for product code ONO

K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Appli (March 13, 2026)
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