FDA.reportPublic FDA data

Visualase V2 MRI-Guided Laser Ablation System

Primary DI
00763000521486
Brand
Visualase V2 MRI-Guided Laser Ablation System
Company
MEDTRONIC NAVIGATION, INC.
Model
9736422
Device description
SYSTEM 9736422 VISUALASE V2 US ONLY
Published
2026-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
ONONeurosurgical laser with MR thermography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONONeurosurgical Laser With Mr ThermographyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250307000Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation2025-05-29ONO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000521486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000521486007630005214867630005214860763000521486

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835233107
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150054398StealthStation S897357622026-08-07
00199150054466N/A97367262026-08-08
00199150057078AXIS AP ROBOTIC TOOL CHANGER 973668197366812026-08-09
00199150067626KIT 9736691 SPINE REFERENCING97366912026-08-07
00199150074396CLAMP 9736433 SPINE STRAIGHT TALL97364332026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUM97364652026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORT97364342026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUM97364672026-08-07
00763000381141N/A97314602026-08-08
00763000989927AXIS HYBRID REF FRAME 973651197365112026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 973651397365132026-08-07
00763000539238SteathStation97364262023-08-04
00763000539108SteathStation97364232022-02-07
00763000539177SteathStation97364262022-02-07
00763000914097Stealth AXiS97365032026-07-24
00763000914035Stealth AXiS97364812026-07-17
00763000914042Stealth AXiS97364822026-07-17
00763000914059Stealth AXiS97364832026-07-17
00763000914066Stealth AXiS97364842026-07-17
00763000914073Stealth AXiS97364852026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000540104VisualaseMEDTRONIC NAVIGATION, INC.ONO2026-03-27
00763000540111VisualaseMEDTRONIC NAVIGATION, INC.ONO2026-03-27
00763000540128VisualaseMEDTRONIC NAVIGATION, INC.ONO2026-03-27
00763000521370VISUALASEMEDTRONIC NAVIGATION, INC.ONO2024-08-03
17340007000956MR IntroducerClinical Laserthermia Systems ABONO2024-05-07
37340007000950MR IntroducerClinical Laserthermia Systems ABONO2024-05-07
00816589021585NeuroBlate NB3 FullFire™ 1.6 Laser ProbeMONTERIS MEDICAL INCONO2024-01-02
17340007000840Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000857Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000864Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000826Mobile Laser UnitClinical Laserthermia Systems ABONO2022-10-28
17340007000833Thermoguide WorkstationClinical Laserthermia Systems ABONO2022-10-28
37340007000844Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
37340007000851Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
37340007000868Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000871Instructions for use Tranberg Thermoguide Therapy System - USClinical Laserthermia Systems ABONO2022-10-28
17340007000888Instructions for Use Laser applicator - NeuroClinical Laserthermia Systems ABONO2022-10-28
00763000521462VisualaseMEDTRONIC NAVIGATION, INC.ONO2022-04-03
00763000416423VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-10-02
00763000416430VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-10-02
00763000416447VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-10-02
00763000402082VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-05-06
00763000402099VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-01-29
00763000313364VisualaseMEDTRONIC NAVIGATION, INC.ONO2020-06-27
00763000357504VisualaseMEDTRONIC NAVIGATION, INC.ONO2020-05-17
00763000218171VisualaseMEDTRONIC NAVIGATION, INC.ONO2019-03-21
00763000218188VisualaseMEDTRONIC NAVIGATION, INC.ONO2019-03-18
00643169933361VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-11
00643169933385VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-11
00643169792890VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-09