510(k) · Cleared

Cleared

Dornier Medilas Fiber Tome Laser

K964760510(k) TraditionalCleared Feb 19, 199784-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 Medtech America, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Feb 19, 1997 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 908 later devices descend from it.

Decided: Feb 19, 1997
Review: 84 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

908 later devices descend from it, 3 citing it directly.

This deviceK964760 Dornier Medilas Fiber Tome LaserDornier Medtech America, Inc. · 1997
Descendant · cites it directly · 698 of its ownK982629 Dornier Medilas DDornier Surgical Products, Inc. · 1998
Descendant · 2 generations on · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
Descendant · 3 generations on · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
Descendant · 4 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
Descendant · 5 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005

Showing 5 of 908 descendants. See all descendants

Descendants cleared per year

1998high 97 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 908 · See all

K982629Dornier Medilas DDornier Surgical Products, Inc. · 1998 · cites it directly698descendants
K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc. · 2002 · 2 generations on695descendants
K030186Polris LVSyneron Medical, Ltd. · 2003 · 3 generations on680descendants
K031671Polaris WRSyneron Medical, Ltd. · 2003 · 4 generations on678descendants
K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 5 generations on476descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K964760	Dornier Medilas Fiber Tome Laser	Dornier Medtech America, Inc.	1997	—
+1	K982629	Dornier Medilas D	Dornier Surgical Products, Inc.	1998	—
+2	K020339	Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D…	Dornier Medtech America, Inc.	2002	—
+3	K030186	Polris LV	Syneron Medical, Ltd.	2003	—
+4	K031671	Polaris WR	Syneron Medical, Ltd.	2003	—
+5	K051214	Aluma Skin Renewal System	Lumenis, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	3	0
1999	3	0
2001	1	0
2002	5	0
2003	6	0
2004	4	0
2005	6	0
2006	7	0
2007	9	0
2008	27	0
2009	21	0
2010	30	0
2011	28	0
2012	31	0
2013	37	0
2014	40	0
2015	35	0
2016	54	0
2017	45	0
2018	44	0
2019	31	0
2020	50	0
2021	40	0
2022	57	0
2023	54	0
2024	79	0
2025	97	0
2026	64	0

FIG. 1 — Lineage of K964760, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (908)

See all 908

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

Number	Device	Applicant	Decided	Descendants
K982629	Dornier Medilas D	Dornier Surgical Products, Inc.	1998	698
K981718	Dornier Medilas H	Dornier Surgical Products, Inc.	1998	348
K080959	Dornier Medilas D 30 Laser, Medilas D 1064	Dornier Medtech America, Inc.	2008	4

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?

Of its descendants, K982629 (Dornier Surgical Products, Inc., 1998) has gone furthest, with 698 descendants of its own.

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	—

https://510kreport.com/device/K964760 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964760: Dornier Medilas Fiber Tome Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964760

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026