FDA.reportPublic FDA data

NA

Primary DI
EOBN220126S0
Brand
NA
Company
OBERON GmbH Fiber Technologies
Model
Laser Surgery Fiber 600µm
Device description
Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 870µm, blue Tefzel Jacket, SMA 905 holmium connector with knurl nut, PEEK protection cap, engraved extension sleeve red, black bend protection, distal flat tip, cleaved, 3mm stripped, NA 0.22, length 3m +/-0,2m, sterile EO, double packed
Published
2021-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K140470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140470000OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBEROberon GmbH Fiber Technologies2014-10-15GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EOBN220126S0PrimaryHIBCC0

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. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
312889060
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
EOBN220105S0NALaser Surgery Fiber 600µm2024-07-24
EOBN210180S0NALaser Surgery Fiber - DiLA’S® Laser PLDD Probe2024-07-17
EOBN210181S0NALaser Surgery Fiber - DiLA’S® Laser Thyroid Probe2024-07-17
EOBN270190S0NALaser Surgery Fiber - DiLA’S® Slenderflex Venous P2024-06-11
EOBN270191S0NALaser Surgery Fiber - DiLA’S® Radial Venous Probe2024-06-11
EOBN270192S0NALaser Surgery Fiber - DiLA’S® Fistula Probe2024-06-11
EOBN270518S0NALaser Surgery Fiber - DiLA’S® Hemorrhoid Probe2024-06-11
EOBN220138S0NALaser Surgery Fiber 600µm2024-01-24
EOBN210135S0NAFiber Optic for MRI red2022-03-17
EOBN210136S0NAFiber Optic for MRI yellow2022-03-17
EOBN210137S0NAFiber Optic for MRI green2022-03-17
EOBN210138S0NAFiber Optic for MRI blue2022-03-17
EOBN270122S0NALaser Surgery Fiber - Radial Emission Fiber 400µm2021-12-23
EOBN270123S0NALaser Surgery Fiber - Radial Emission Fiber 600µm2021-12-23
EOBN210167S0NALaser Surgery Fiber 600µm2021-08-16
EOBN200029S0NALaser Surgery Fiber 600µm 2.6m2017-06-09
EOBN210110S0NAFiber Optic for PLA Short red2019-01-15
EOBN210111S0NAFiber Optic for PLA Short yellow2019-01-15
EOBN210112S0NAFiber Optic for PLA Short green2019-01-15
EOBN210113S0NAFiber Optic for PLA Short blue2019-01-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390090Twain EvoQUANTA SYSTEM SPAGEX2018-12-14