# K113858: Megabeam Endo-Ent Probe

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Medical Devices, Inc.
- Decided: Jan 24, 2012 after 25 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: 1 generation back to K952772 (1995). 1 ancestor in all.
24 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952772: Megabeam Endo-Ent Probe, Ceram Optec, Inc. (1995) Summary page 1.

## Most influential descendants
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe (2013), 23 descendants of its own
- K170366: Laser Peripherals, LLC Family of Bare Laser Fibers (2017), 13 descendants of its own
- K220189: LISA Laser Surgical Fibers (2022), 5 descendants of its own
- K140470: Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber (2014), 5 descendants of its own
- K131473: (Quanta System) Surgical Laser Fibers (2013), 5 descendants of its own

## Indications for use
The MegaBeam Endo-ENT Probe is intended as an aid for otologic procedures, for use in incision, excision, coagulation and. vaporization of soft and fibrous tissue including osseous tissue. It is indicated for ENT surgery for use with compatible lasers cleared for use in the desired application.

Source page: https://510kreport.com/device/K113858
Methodology: https://510kreport.com/methodology