FDA.reportPublic FDA data

NA

Primary DI
EOBN230051N0
Brand
NA
Company
OBERON GmbH Fiber Technologies
Model
Laser Surgery Fiber - Dental Bare Fiber 200µm
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
EOBN230051N0PrimaryHIBCC0

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
EOBN210188S0NALaser Surgery Fiber 272µm2026-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16