510(k) · Cleared

Cleared

Megapulse Laser System and Fibers

K090776510(k) TraditionalCleared Jun 2, 200971-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Richard Wolf Medical Instruments Corp. · GEX Powered Laser Surgical Instrument

Cleared on Jun 2, 2009 as substantially equivalent to K001243 (Dornier Surgical Products, Inc., 2000) and 5 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Jun 2, 2009
Review: 71 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K943445 (1994). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK943445 Megabeam Fiber Optic Delivery SystemCeram Optec, Inc. · 1994
This deviceK090776 Megapulse Laser System and FibersRichard Wolf Medical Instruments Corp. · 2009
Descendant · cites it directly · 0 of its ownK122368 Waterlase Iplus All Tissue LaserBiolase Technology, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all

K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943445	Megabeam Fiber Optic Delivery System	Ceram Optec, Inc.	1994	—
0 (this device)	K090776	Megapulse Laser System and Fibers	Richard Wolf Medical Instruments Corp.	2009	—
+1	K122368	Waterlase Iplus All Tissue Laser	Biolase Technology, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	2	0
2002	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K090776, 1994–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K001243	Dornier Medilas H Summary page 1 …formation on devices to which substantial equivalence is claimed: 510(k Number Trade or proprietary or model name Manufacturer 1 K00 1243 1 Dornier Medilas H Laser 1 Domier 2 K002308 2 Trinmedyne OmniPulse Models 121…	Dornier Surgical Products, Inc.	2000	—
*	K002308	Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model… Summary page 1 …Trade or proprietary or model name Manufacturer 1 K00 1243 1 Dornier Medilas H Laser 1 Domier 2 K002308 2 Trinmedyne OmniPulse Models 1210, 1210-VHF, and 2 Trinmedyne, Inc. ____________ 1500-A…	Trimedyne, Inc.	2000	—
*	K051399	Wavelight Auriga Summary page 1 …nmedyne OmniPulse Models 1210, 1210-VHF, and 2 Trinmedyne, Inc. ____________ 1500-A _________________ 3 K051399 .3 AURIGA 3 WaveLight Laser Tech., AG. Trade name:…	Wavelight Laser Technologie AG	2005	—
*	K022544	Dornier Medilas H Laser Fiber Cables Summary page 1 …GEX) Information on devices to which substantial equivalence is claimed: 5 10(k) Number Trade or proprietary or model name Manufacturer K022 544 1. Dornier Medilas H Laser Fiber Cables 1. Dornier MedTech America, Inc. K943445 2. Megabeam Fiber Opti…	Dornier Medtech America, Inc.	2002	—
*	K943445	Megabeam Fiber Optic Delivery System Summary page 1 …Trade or proprietary or model name Manufacturer K022 544 1. Dornier Medilas H Laser Fiber Cables 1. Dornier MedTech America, Inc. K943445 2. Megabeam Fiber Optic Delivery System 2. Ceramoptec, Inc. (Biolitec, Inc.) K973 172 3. Resposable Holm…	Ceram Optec, Inc.	1994	—
*	K973172	Resposable Bare Fibers Summary page 1 …s H Laser Fiber Cables 1. Dornier MedTech America, Inc. K943445 2. Megabeam Fiber Optic Delivery System 2. Ceramoptec, Inc. (Biolitec, Inc.) K973 172 3. Resposable Holmnium Bare Fibers 3. Trimedyne, Inc. Section…	Trimedyne, Inc.	1998	—

Also cleared against K001243: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K122368	Waterlase Iplus All Tissue Laser	Biolase Technology, Inc.	2013	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 6 ancestors has a recall.
Of its descendants, K122368 (Biolase Technology, Inc., 2013) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K001243.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090776 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090776: Megapulse Laser System and Fibers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090776

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026