510(k) · Cleared

Cleared

Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30

K051996510(k) SpecialCleared Aug 18, 200524-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

Diomed, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Aug 18, 2005 as substantially equivalent to K013499 (Diomed, Inc., 2001) and 3 other predicates after a 24-day review. Its family tree reaches back 9 generations to 1995. 89 later devices descend from it.

Decided: Aug 18, 2005
Review: 24 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 4

Its longest line of descent runs back 9 generations to K943450 (1995). 27 ancestors in all, the oldest K800617 (1980). 89 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
5 generations between
3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
2 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
1 generation backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
This deviceK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
Descendant · cites it directly · 80 of its ownK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
Descendant · 2 generations on · 78 of its ownK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Descendant · 2 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Descendant · 2 generations on · 33 of its ownK120235 Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag…Aerolase Medical Lasers, LLC · 2012

Show all 9 generations

Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
5 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
4 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
2 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
1 generation backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
This deviceK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005

Showing 5 of 89 descendants. See all descendants

Descendants cleared per year

2007high 12 (2022) · low 0 (2013)2026

Most influential descendants

Showing 5 of 89 · See all

K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D. · 2009 · cites it directly80descendants
K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D. · 2011 · 2 generations on78descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 2 generations on62descendants
K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC · 2012 · 2 generations on33descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K943450	Arthrocare Arthroscopic Electrosurgery System Model 970	Arthrocare Corp.	1995	—
−8	K961069	Arthrocare Urologic Multi-Electrode Electrosurgery System	Arthrocare Corp.	1996	—
−7	K962445	Arthrocare Dental Electrosurgery System	Arthrocare Corp.	1996	—
−6	K964849	Arthrocare Dermatologic Electrosurgery System	Arthrocare Corp.	1997	—
−5	K971532	Arthrocare Electrosurgery System	Arthrocare Corp.	1997	—
−4	K974521	Vnus Closure System	Vnus Medical Technologies, Inc.	1998	—
−3	K982816	Vnus Closure System	Vnus Medical Technologies, Inc.	1999	—
−2	K012398	Diomed 15 Diode Laser	Diomed, Ltd.	2002	—
−1	K041957	Evlt Kit and the D15PLUS and D30PLUS Diode Lasers	Diomed, Inc.	2004	1
0 (this device)	K051996	Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30	Diomed, Ltd.	2005	—
+1	K090126	Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP…	Fotona D.D.	2009	—
+2	K101306	SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…	Fotona D.D.	2011	—
+3	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—
+2	K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015	—
+2	K120235	Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers…	Aerolase Medical Lasers, LLC	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1985	1	0
1995	2	0
1996	5	0
1997	6	0
2000	1	0
2001	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2011	1	0
2012	2	0
2014	2	0
2015	3	0
2016	3	0
2017	4	0
2018	5	0
2019	3	0
2020	5	0
2021	5	0
2022	12	0
2023	7	0
2024	10	0
2025	12	0
2026	11	0

FIG. 1 — Lineage of K051996, 1995–2026Source: 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? (4)

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
*	K013499	Diomed 15 Plus and Diomed 30PLUS Lasers Summary page 1 …3. Predicate Devices The Diomed Delta I5and Diomed Delta 30 Lasers are substantially equivalent to the Diomed Dl5Plus and D3OPlus Diode Lasers (K013499, K012398, K023543, K041957). 4. Device Description The purpose of this Special 5 10(k) is to notify FD…	Diomed, Inc.	2001	—
*	K012398	Diomed 15 Diode Laser Summary page 1 …redicate Devices The Diomed Delta I5and Diomed Delta 30 Lasers are substantially equivalent to the Diomed Dl5Plus and D3OPlus Diode Lasers (K013499, K012398, K023543, K041957). 4. Device Description The purpose of this Special 5 10(k) is to notify FDA of the…	Diomed, Ltd.	2002	—
*	K023543	Evlt Kit and D15PLUS and D30PLUS Diode Summary page 1 …Devices The Diomed Delta I5and Diomed Delta 30 Lasers are substantially equivalent to the Diomed Dl5Plus and D3OPlus Diode Lasers (K013499, K012398, K023543, K041957). 4. Device Description The purpose of this Special 5 10(k) is to notify FDA of the proposed…	Diomed, Inc.	2002	—
*	K041957	Evlt Kit and the D15PLUS and D30PLUS Diode Lasers Summary page 1 …The Diomed Delta I5and Diomed Delta 30 Lasers are substantially equivalent to the Diomed Dl5Plus and D3OPlus Diode Lasers (K013499, K012398, K023543, K041957). 4. Device Description The purpose of this Special 5 10(k) is to notify FDA of the proposed new Di6med…	Diomed, Inc.	2004	1

Also cleared against K013499: 1 other device →

What descends from it? (89)

See all 89

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

Number	Device	Applicant	Decided	Descendants
K090126	Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…	Fotona D.D.	2009	80
K063828	Diomed Delta 25	Diomed, Ltd.	2007	5
K080959	Dornier Medilas D 30 Laser, Medilas D 1064	Dornier Medtech America, Inc.	2008	4
K243701	AuroLase® System	Nanospectra Biosciences, Inc.	2025	0
K093502	Vari-Lase Endovenous Laser Console	Vascular Solutions, Inc.	2010	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 10 years and passes through 4 companies; a new generation was cleared every 9 months on median.
2 of the 27 ancestors have a recall of any class.
Of its descendants, K090126 (Fotona D.D., 2009) has gone furthest, with 80 descendants of its own.
1 other device also cites its predicate K013499.

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?

General Surgery

Ophthalmology/Oculoplastic

Urology

Gastroenterology

Gynecology

Otorhinolaryngology

Pulmonary/Thoracic

Dermatology/Plastic Surgery

Neurosurgery (coagulation only)

Orthopedic

Treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein.

Treatment of incompetent refluxing veins in the superficial venous system in the lower limb

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051996 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051996: Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051996

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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