# K980838: Reusable Megabeam Fiber Optic Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Jun 2, 1998 after 90 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: 2 generations back to K902990 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923953: Megabeam, Ceram Optec, Inc. (1992) Summary page 1.
- K943445: Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 1.
- K951775: Ceralas Diode Laser System (Model Ceralas D50), Ceram Optec, Inc. (1995) Summary page 1.
- K960413: Coherent Slimline Single Lumen Aspiration Needle Kit, Lumenis, Inc. (1996) Summary page 1.

## Most influential descendants
- K113688: Megabeam Reusable Fiber Optic Delivery System (2012), 0 descendants of its own

## Indications for use
The reusable MegaBeam Fiber Optic Delivery System is intended for use as an accessory to a Ho:YAG laser system to vaporize, coagulate, and incise and excise tissue, including lithrotripsy. The MegaBeam Fiber Optic Delivery System is also intended to be used in lithotripsy proccdures with Ho:YAG laser systems.

Source page: https://510kreport.com/device/K980838
Methodology: https://510kreport.com/methodology