510(k) · Cleared

Cleared

Dornier Medilas H/2

K984591510(k) TraditionalCleared Mar 26, 199988-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

Dornier Surgical Products, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Mar 26, 1999 as substantially equivalent to K983963 (Dornier Medtech America, Inc., 1998) after an 88-day review. Its family tree reaches back 3 generations to 1997. 344 later devices descend from it.

Decided: Mar 26, 1999
Review: 88 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K964760 (1997). 344 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK964760 Dornier Medilas Fiber Tome LaserDornier Medtech America, Inc. · 1997
2 generations backK981718 Dornier Medilas HDornier Surgical Products, Inc. · 1998
1 generation backK983963 Dornier Medila HDornier Medtech America, Inc. · 1998
This deviceK984591 Dornier Medilas H/2Dornier Surgical Products, Inc. · 1999
Descendant · cites it directly · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
Descendant · 2 generations on · 136 of its ownK083616 Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009
Descendant · 2 generations on · 136 of its ownK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
Descendant · 3 generations on · 122 of its ownK093545 Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010
Descendant · 4 generations on · 121 of its ownK103626 Cutera Genesisplus Laser SystemCutera, Inc. · 2011

Showing 5 of 344 descendants. See all descendants

Descendants cleared per year

2001high 32 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 344 · See all

K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · cites it directly342descendants
K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009 · 2 generations on136descendants
K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009 · 2 generations on136descendants
K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010 · 3 generations on122descendants
K103626Cutera Genesisplus Laser SystemCutera, Inc. · 2011 · 4 generations on121descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K964760	Dornier Medilas Fiber Tome Laser	Dornier Medtech America, Inc.	1997	—
−2	K981718	Dornier Medilas H	Dornier Surgical Products, Inc.	1998	—
−1	K983963	Dornier Medila H	Dornier Medtech America, Inc.	1998	—
0 (this device)	K984591	Dornier Medilas H/2	Dornier Surgical Products, Inc.	1999	—
+1	K011703	Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…	Lumenis	2001	2
+2	K083616	Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag Lasers	Patholase, Inc.	2009	—
+2	K083215	Incisive Family of Inpulse ND:Yag Lasers	Incisive, LLC	2009	—
+3	K093545	Pinpointe Footlaser Model 6W, 30W, 100W	Incisive, Inc. (Formerly Named Incisive, LLC)	2010	—
+4	K103626	Cutera Genesisplus Laser System	Cutera, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	3	0
2003	4	0
2004	3	0
2005	4	0
2006	3	0
2007	1	0
2008	9	0
2009	4	0
2010	11	0
2011	13	0
2012	18	0
2013	21	0
2014	15	0
2015	15	0
2016	26	0
2017	16	0
2018	15	0
2019	11	0
2020	20	0
2021	15	0
2022	19	0
2023	20	0
2024	20	0
2025	32	0
2026	25	0

FIG. 1 — Lineage of K984591, 1997–2026Source: 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? (1)

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
*	K983963	Dornier Medila H Our OCR of the scanned summary read K883963, FDA’s number for Raney and Leroy-Raney Scalp Clip (New England Surgical Instrument Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Dornier Medilas H Laser System”.	Dornier Medtech America, Inc.	1998	—

Also cleared against K983963: 1 other device →

What descends from it? (344)

See all 344

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K011703	Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…	Lumenis	2001	342
K032023	W.O.M. Laser U100PLUS	W.O.M. World of Medicine AG	2003	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?

The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 4 months on median.
None of the 3 ancestors has a recall.
Of its descendants, K011703 (Lumenis, 2001) has gone furthest, with 342 descendants of its own.
1 other device also cites its predicate K983963.

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.

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 Dornier Medilas H/2 Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).

The Dornier Medilas H is indicated for use in medicine and surgery, in the fbllowing medical specialties: Urology, Gastroenterology, Arthroscopy, ENT, General Surgery, Lithotripsy, Pulmonology, Gynecology

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K984591 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984591: Dornier Medilas H/2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984591

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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