510(k) · Cleared

Cleared

Dornier Medilas D

K982629510(k) TraditionalCleared Sep 14, 199848-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 Sep 14, 1998 as substantially equivalent to K964760 (Dornier Medtech America, Inc., 1997) and 1 other predicate after a 48-day review. Its family tree reaches back 1 generation to 1996. 698 later devices descend from it.

Decided: Sep 14, 1998
Review: 48 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K955758 (1996). 2 ancestors in all. 698 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK955758 Indigo Medical Model Idl 830EIndigo Medical, Inc. · 1996
This deviceK982629 Dornier Medilas DDornier Surgical Products, Inc. · 1998
Descendant · cites it directly · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
Descendant · 2 generations on · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
Descendant · 3 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
Descendant · 4 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
Descendant · 3 generations on · 456 of its ownK052324 Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005

Showing 5 of 698 descendants. See all descendants

Descendants cleared per year

1999high 88 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 698 · See all

K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc. · 2002 · cites it directly695descendants
K030186Polris LVSyneron Medical, Ltd. · 2003 · 2 generations on680descendants
K031671Polaris WRSyneron Medical, Ltd. · 2003 · 3 generations on678descendants
K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 4 generations on476descendants
K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005 · 3 generations on456descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955758	Indigo Medical Model Idl 830E	Indigo Medical, Inc.	1996	—
0 (this device)	K982629	Dornier Medilas D	Dornier Surgical Products, Inc.	1998	—
+1	K020339	Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D…	Dornier Medtech America, Inc.	2002	—
+2	K030186	Polris LV	Syneron Medical, Ltd.	2003	—
+3	K031671	Polaris WR	Syneron Medical, Ltd.	2003	—
+4	K051214	Aluma Skin Renewal System	Lumenis, Inc.	2005	—
+3	K052324	Polaris LV, Lva Applicator	Syneron Medical, Ltd.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	2	0
2003	2	0
2004	1	0
2005	2	0
2006	3	0
2007	8	0
2008	18	0
2009	17	0
2010	19	0
2011	15	0
2012	17	0
2013	21	0
2014	29	0
2015	25	0
2016	39	0
2017	35	0
2018	35	0
2019	25	0
2020	40	0
2021	32	0
2022	51	0
2023	45	0
2024	76	0
2025	88	0
2026	52	0

FIG. 1 — Lineage of K982629, 1996–2026Source: 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? (2)

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
*	K964760	Dornier Medilas Fiber Tome Laser Summary page 1 …ed upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which includes the following: Dornier 5100 Laser (K964760) and Indigo’s 830e (K955758). Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Dornier Surgical P…	Dornier Medtech America, Inc.	1997	—
*	K955758	Indigo Medical Model Idl 830E Summary page 1 …e substantial equivalence as well as the safety and effectiveness of its predicate devices which includes the following: Dornier 5100 Laser (K964760) and Indigo’s 830e (K955758). Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Dornier Surgical Products, Inc. Phone: 770-426-…	Indigo Medical, Inc.	1996	—

Also cleared against K964760: 2 other devices →

What descends from it? (698)

See all 698

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

Number	Device	Applicant	Decided	Descendants
K020339	Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…	Dornier Medtech America, Inc.	2002	695
K021724	Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas…	Dornier Medtech America, Inc.	2002	305
K070536	Medilas D Family Lasers	Dornier Medtech America, Inc.	2007	197
K073427	Medilas D Family Lasers	Dornier Medtech America, Inc.	2008	81
K094049	Stlase Diode Laser	Dental Photonics, Inc.	2010	23
K991183	Dornier Lasertrode Fiber	Dornier Surgical Products, Inc.	1999	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 2 ancestors has a recall.
Of its descendants, K020339 (Dornier Medtech America, Inc., 2002) has gone furthest, with 695 descendants of its own.
2 other devices also cite its predicate K964760.

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 D 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 D is indicated for use in medicine and surgery, in the following medical specialties:

Urology

Pulmonary Surgery

Plastic Surgery

Gastroenterology

General Surgery

ENT

Dermatology

Radiology

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/K982629 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982629: Dornier Medilas D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982629

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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