# K113709: Megabeam Fiber Optic Delivery System with Additional Tips & Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Medical Devices, Inc.
- Decided: Jan 20, 2012 after 32 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 K923953 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946336: Megabeam Fiber Optic Delivery System, Hogan & Hartson (1995) Summary page 1.
- K923953: Megabeam, Ceram Optec, Inc. (1992) Summary page 1.
- K943445: Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 1.

## Indications for use
The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece 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/K113709
Methodology: https://510kreport.com/methodology