FDA.reportPublic FDA data

Laser Surgery Fibers and Probes

Primary DI
04260155591198
Brand
Laser Surgery Fibers and Probes
Company
A.R.C. Laser GmbH
Model
LL13015s
Catalog number
LL13015s
Device description
Endoprobe 30° 25 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
04260155591617PackageGS115In Commercial Distribution
4260155591822PackageGS130In Commercial Distribution
04260155591198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260155591617042601555916174260155591617
4260155591822042601555918224260155591822
04260155591198042601555911984260155591198

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
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
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