# K140470: Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Oberon GmbH Fiber Technologies
- Decided: Oct 15, 2014 after 232 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 400 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 406 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe, Med-Fibers, Inc. (2013)
- K120810: Fiberoptic Laser Delivery System, Fiberoptic Fabrications, Inc. (2012)
- (no number) Laser Peripherals fiber optic laser delivery system: named in the summary without a submission number
- (no number) Leoni fiber optic laser delivery system: named in the summary without a submission number
- (no number) Lumenis fiber optic laser delivery system: named in the summary without a submission number
- (no number) Cynosure fiber optic laser delivery system: named in the summary without a submission number
- (no number) CermaOptec fiber optic laser delivery system: named in the summary without a submission number

## Most influential descendants
- K152417: Adler MicroMed Laser Surgery Fibers (2015), 3 descendants of its own
- K232769: BeaMed Laser Surgery Fibers (2023), 1 descendant of its own
- K250113: neoLaser Laser Surgery Fibers (2025), 0 descendants of its own
- K161403: A.R.C. Laser Surgical Fibers and Probes (2016), 0 descendants of its own
- K151855: SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber (2016), 0 descendants of its own

## Indications for use
The OBERON, laser surgery fiber, Side Fire laser surgery fibers are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers are indicated for use in general surgery applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. (Diode Laser 532nm- 2100nm) OBERON laser surgery fiber is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, Nd;YAG, 1.44YAG and Diode Lasers (532nm - 2100nm) with peak and continuous power from 1-100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

Source page: https://510kreport.com/device/K140470
Methodology: https://510kreport.com/methodology