FDA.reportPublic FDA data

Laser Surgery Fibers and Probes

Primary DI
04260155590351
Brand
Laser Surgery Fibers and Probes
Company
A.R.C. Laser GmbH
Model
LL13006s
Catalog number
LL13006s
Device description
Endo Probe 23 Gauge
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
04260155591532PackageGS115In Commercial Distribution
04260155591747PackageGS130In Commercial Distribution
04260155592942PackageGS15In Commercial Distribution
04260155590351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260155591532042601555915324260155591532
04260155591747042601555917474260155591747
04260155592942042601555929424260155592942
04260155590351042601555903514260155590351

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
04260155590498Laser Surgery Fibers and ProbesLL13014sLL13014s2016-10-28
04260155591020Laser Surgery Fibers and ProbesLL28001s LL28001s 2016-10-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
06970745912927ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912934ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912996ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
04053002150316Bare Fiber 400 T Luer LockLight Guide Optics International SIAGEX2026-08-14
04053002150415Bare Fiber 600 T Luer LockLight Guide Optics International SIAGEX2026-08-14
04053002150514CORONA 360 Fused 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
04053002150613CORONA Infinite Ring XSCF 600 1.6 USLight Guide Optics International SIAGEX2026-08-14
04053002150712Rigid Infinite Ring HSC Probe 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
06973011720080CO2 Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-08-07
06973011720103Q Switched Nd: YAG Laser machineSanhe LEFIS Electronics Co., LtdGEX2026-08-07
00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.GEX2026-08-03
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16