Oberon Laser Surgery Fiber
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Laser Fiber EUDAMED
- Model / Reference
- Reusable Laser Surgery Fibers, non-sterile EUDAMED220077N EUDAMED220078N EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EOBN220077N0P EUDAMED+EOBN220078N0Q EUDAMED
- Basic UDI-DI
- ++EOBNLSFreuseNS2 EUDAMED
- Direct Marketing DI
- +EOBN220077N0P EUDAMED+EOBN220078N0Q EUDAMED
- 510(k) Number
- K140470 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Oberon Laser Surgery Fiber is a Side Fire Fiber, Radial Emission Fiber designed for laser-based surgical procedures. It delivers laser energy to soft tissue in both contact and non-contact modes, including through endoscopic and cystoscopic applications. Its atraumatic design minimizes tissue trauma during use, making it suitable for delicate surgical interventions.
This fiber is supplied as a reusable medical device and is classified under Powered Laser Surgical Instruments (Regulation 878.4810). It is intended for general plastic surgery applications and has received FDA 510(k) clearance (K140470) under the Substantially Equivalent determination. Compliance with MDR requirements is also noted. No specific sterility or MRI safety information is provided in the available data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber ..., OBERON Fiber Technologies Start - Oberon, OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY… - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K140470 | Class II | Active |
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Manufacturer
- Manufacturer
- Oberon GmbH Fiber Technologies
Sources (3)
- FDA 510(k) K140470 24 fields · synced Sep 18, 2026
- EUDAMED f6457d76-cc64-42e1-95f1-102e34598cc8 61 fields · synced Aug 2, 2026
- EUDAMED 906705e7-3dbd-4847-b569-032c12d4b8ec 61 fields · synced Sep 17, 2026