FDA.reportPublic FDA data

Visualase

Primary DI
00763000540128
Brand
Visualase
Company
MEDTRONIC NAVIGATION, INC.
Model
9735561
Device description
VCLAS 9735561 15MM TIP/1.85MM CATHETER
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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
K253391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253391000Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)Medtronic Navigation, Inc.2026-03-13ONO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000540128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000540128007630005401287630005401280763000540128

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.

Contacts#

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

Regulatory Flags#

DUNS number
835233107
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150071968Stealth AXiS Leica Kit97367562026-09-25
00199150071975Stealth AXiS Kinevo 900 Kit97367572026-09-25
00199150071982Stealth AXiS Pentero 900 Kit97367582026-09-25
00199150054404ZEISS TIVATO 70097367222026-09-21
00199150054442ZEISS PENTERO 800S97367242026-09-21
00199150067633Stealth AXiS Advanced Spine Referencing Kit97366922026-09-06
00763000994501Stealth AXiS Spine Referencing Kit SS97366962026-09-06
00763000994525Stealth AXiS Advanced Spine Referencing Kit SS97366972026-09-06
00763000994549Stealth AXiS EM Emitter Arm Bed Kit SS97366982026-09-06
00763000994563Stealth AXiS EM Spine Retractors Kit SS97366992026-09-06
00763000384234N/A97361462021-08-13
00199150071593Stealth AXiS™ 3D-to-Fluoro Round Adapter Kit97367642026-08-22
00199150071616Stealth AXiS™ 3D-to-Fluoro Flat Adapter Kit97367662026-08-22
00763000989972Stealth AXiS™ 3D-to-Fluoro Flat C-arm Tracker97365192026-08-22
00763000989989Stealth AXiS™ 3D-to-Fluoro Round C-arm Tracker97365332026-08-22
00763000994587Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT Stainless Steel97367002026-08-17
00199150067664Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT97366952026-08-15
00763000989958Stealth AXiS™ GEHC Craniotomy Transducer Tracker97365172026-08-15
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification Device97365182026-08-15
00763000995195Stealth AXiS97366722026-08-14

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
00763000521486Visualase V2 MRI-Guided Laser Ablation SystemMEDTRONIC NAVIGATION, INC.ONO2026-02-02
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