Visualase V2 MRI-Guided Laser Ablation System

GUDID 00763000521486

SYSTEM 9736422 VISUALASE V2 US ONLY

MEDTRONIC NAVIGATION, INC.

General/multiple surgical diode laser system

• Primary Device ID: 00763000521486
• NIH Device Record Key: 8c6d196a-3ddc-49bb-a1fc-37c75ad26069
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visualase V2 MRI-Guided Laser Ablation System
• Version Model Number: 9736422
• Company DUNS: 835233107
• Company Name: MEDTRONIC NAVIGATION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000521486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250307

FDA Product Code

• ONO: Neurosurgical laser with MR thermography

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-10
• Device Publish Date: 2026-02-02

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

• 00763000521486 - Visualase V2 MRI-Guided Laser Ablation System: 2026-02-10SYSTEM 9736422 VISUALASE V2 US ONLY
• 00763000521486 - Visualase V2 MRI-Guided Laser Ablation System: 2026-02-10 SYSTEM 9736422 VISUALASE V2 US ONLY
• 00763000738488 - AxiEM™: 2026-01-09 STYLET 9735428 2 COIL SINGLE PACKAGE
• 00613994462428 - O-Arm: 2025-12-05 CONTROLLER 9733292R WIRELESS O-ARM RWK
• 00763000255565 - N/A: 2025-09-29 TRIAL 9734663 CLYDESDALE 14X50MM
• 00763000255589 - N/A: 2025-09-29 TRIAL 9734664 CLYDESDALE 14X55MM
• 00199150014699 - NavLock™: 2025-09-26 INST SET 9734492 SOLERA DEF UPGRADE
• 00199150014729 - SOLERA: 2025-09-26 INST SET 9735284 SOLERA NONCAN TAPS
• 00199150014736 - SOLERA: 2025-09-26 INST SET 9735285 SOLERA ILIAC TAPS A^