FDA.reportPublic FDA data

Laser Surgery Fibers and Probes

Primary DI
04260155591020
Brand
Laser Surgery Fibers and Probes
Company
A.R.C. Laser GmbH
Model
LL28001s
Catalog number
LL28001s
Device description
Bare Fiber 300µm
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K161403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161403000A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH2016-08-16GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260155591563PackageGS115In Commercial Distribution
04260155591778PackageGS130In Commercial Distribution
04260155592935PackageGS15In Commercial Distribution
04260155591020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260155591563042601555915634260155591563
04260155591778042601555917784260155591778
04260155592935042601555929354260155592935
04260155591020042601555910204260155591020

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
314885641
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260155590078Diode laser FOX 980 nm.LS03200LS032002019-05-08
04260155592546Diode Laser Wolf 445nmLS11000LS110002020-07-09
04260155593017Diode laser FOX 1064 nm.LS03200LS032002019-11-19
04260155590351Laser Surgery Fibers and ProbesLL13006sLL13006s2016-10-28
04260155590498Laser Surgery Fibers and ProbesLL13014sLL13014s2016-10-28
04260155591044Laser Surgery Fibers and ProbesLL28008sLL28008s2016-10-28
04260155591068Laser Surgery Fibers and ProbesLL13001sLL13001s2016-10-28
04260155591082Laser Surgery Fibers and ProbesLL13003sLL13003s2016-10-28
04260155591099Laser Surgery Fibers and ProbesLL13008sLL13008s2016-10-28
04260155591198Laser Surgery Fibers and ProbesLL13015sLL13015s2016-10-28
04260155591204Laser Surgery Fibers and ProbesLL13025sLL13025s2016-10-28
04260155591358Laser Surgery Fibers and ProbesLL11053s LL11053s 2016-10-28
04260155591433Laser Surgery Fibers and ProbesLL11058sLL11058s2016-10-28
04260155591440Laser Surgery Fibers and ProbesLL11059sLL11059s2016-10-28
04260155591457Laser Surgery Fibers and ProbesLL13009sLL13009s2016-10-28
04260155591464Laser Surgery Fibers and ProbesLL13010sLL13010s2016-10-28
04260155591471Laser Surgery Fibers and ProbesLL13017s LL13017s 2016-10-28
04260155591488Laser Surgery Fibers and ProbesLL13034sLL13034s2016-10-28
04260155591495Laser Surgery Fibers and ProbesLL28006s LL28006s 2016-10-28
04260155591501Laser Surgery Fibers and ProbesLL28058sLL28058s2016-10-28

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Primary DI, Brand, Company table
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