FDA.reportPublic FDA data

NA

Primary DI
EOBN210188S0
Brand
NA
Company
OBERON GmbH Fiber Technologies
Model
Laser Surgery Fiber 272µm
Device description
Laser Surgery Fiber, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon, standard SMA 905 connector with knurl nut, black protection cap, RFID extension sleeve red with HID Glass Tag HF VIGO, black bend protection, distal flat tip, cleaved, NA 0.22, length 2m +/-0,2m, sterile EO, disposable, double packed,
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
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
EOBN210188S0PrimaryHIBCC0

GMDN Terms#

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

Regulatory Flags#

DUNS number
312889060
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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