# K090776: Megapulse Laser System and Fibers

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Jun 2, 2009 after 71 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 K943445 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001243: Dornier Medilas H, Dornier Surgical Products, Inc. (2000) Summary page 1.
- K002308: Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model 1210-VHP and 1500-a, Trimedyne, Inc. (2000) Summary page 1.
- K051399: Wavelight Auriga, Wavelight Laser Technologie AG (2005) Summary page 1.
- K022544: Dornier Medilas H Laser Fiber Cables, Dornier Medtech America, Inc. (2002) Summary page 1.
- K943445: Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 1.
- K973172: Resposable Bare Fibers, Trimedyne, Inc. (1998) Summary page 1.

## Most influential descendants
- K122368: Waterlase Iplus All Tissue Laser (2013), 0 descendants of its own

## Indications for use
The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, and colonscopic) procedures, breaking up stones, cutting (i.e. structures), ablation, vaporization, excision, incision, and coagulation of tissue in the specialties as: Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery.

Source page: https://510kreport.com/device/K090776
Methodology: https://510kreport.com/methodology