FDA.reportPublic FDA data

Visualase

Primary DI
00643169590076
Brand
Visualase
Company
MEDTRONIC NAVIGATION, INC.
Model
9735552
Device description
LASER 9735552 15W 980NM - VISUALASE
Published
2016-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered laser surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081656000VISUALASE THERMAL THERAPY SYSTEMBiotex, Inc.2008-09-10LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169590076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169590076006431695900766431695900760643169590076

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, 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
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

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Primary DI, Brand, Company table
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