FDA.reportPublic FDA data

Dornier MedTech

Primary DI
04049958000225
Brand
Dornier MedTech
Company
Dornier MedTech GmbH
Model
Medilas D MultiBeam (D-Plug)
Catalog number
K2011691
Device description
Medilas D MultiBeam Diode Laser, D-Plug
Published
2018-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K070536000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070536000MEDILAS D FAMILY LASERSDornier Medtech America, Inc.2007-05-21GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049958000225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049958000225040499580002254049958000225

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

Regulatory Flags#

DUNS number
388104085
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049958000218Dornier MedTechMedilas D LiteBeam+ (D-Plug)K20116272018-09-11
04049958001307Dornier MedTechMedilas D FlexiPulse (D-Plug)K20117432018-09-11
04049958001383Dornier MedTechMedilas D MultiBeam (D-Plug)K20119152018-09-13
04049958002090Dornier MedTechMedilas D30 1064 (SMA)K20120152018-09-12
04049958002229Dornier MedTechMedilas D LiteBeam+ (1470 SMA)K20124012018-09-13
04049958002441Dornier MedTechMedilas D LiteBeam+ (1470 D-Plug)K20129572018-09-11
04049958001468Dornier MedTech600 Micron Disposable K10080842018-09-11
04049958001529Dornier MedTech600 Micron Disposable Nozzle TipK10012912018-09-11
04049958001536Dornier MedTech600 Micron Disposable Nozzle TipK10012922018-09-11
04049958001543Dornier MedTech600 Micron Disposable Nozzle TipK10012932018-09-11
04049958001673Dornier MedTech600 Micron Disposable BarefiberK10105002018-09-12
04049958001789Dornier MedTech400 Micron Disposable NA 0.37K20107102018-09-11
04049958001925Dornier MedTech600 Micron Disposable K20121462018-09-11
04049958002120Dornier MedTech400 Micron Disposable NA 0.37K20118222018-09-13
04049958002144Dornier MedTech600 Micron Disposable K20118242018-09-11
04049958004551Dornier ThulioK2016000K20160002023-01-27
04049958000065Dornier MedTech600 Micron Disposable Rinsing TubeK10012952018-09-11
04049958000171Dornier MedTechMedilas Fibertome 8100K20115002018-09-13
04049958001741Dornier MedTech400 Micron Disposable NA 0.22K20102912018-09-11
04049958002113Dornier MedTech550 Micron 5X Reusable K20124392018-09-11

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Primary DI, Brand, Company table
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