# K113688: Megabeam Reusable Fiber Optic Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Medical Devices, Inc.
- Decided: Mar 13, 2012 after 89 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: 3 generations back to K902990 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980838: Reusable Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (1998) Summary page 1.

## Indications for use
The MegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.

Source page: https://510kreport.com/device/K113688
Methodology: https://510kreport.com/methodology