FDA.reportPublic FDA data

NA

Primary DI
EOBN230052N0
Brand
NA
Company
OBERON GmbH Fiber Technologies
Model
Laser Surgery Fiber - Dental Bare Fiber 320µm
Published
2019-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
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
EOBN230052N0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-use, sterileA sterile, 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
312889060
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
EOBN220126S0NALaser 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
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