510(k) · Cleared

Cleared

Diomed 15 Plus and Diomed 30PLUS Lasers

K013499510(k) SpecialCleared Nov 16, 200125-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, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Nov 16, 2001 as substantially equivalent to K962354 (Lifestream Int'L, Inc., 1996) after a 25-day review. Its family tree reaches back 1 generation to 1996. 298 later devices descend from it.

Decided: Nov 16, 2001
Review: 25 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962354 (1996). 298 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK962354 Diomed 15, 30, 60 Surgical Diode LaserLifestream Int'L, Inc. · 1996
This deviceK013499 Diomed 15 Plus and Diomed 30PLUS LasersDiomed, Inc. · 2001
Descendant · cites it directly · 297 of its ownK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
Descendant · 2 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
Descendant · 3 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Descendant · 2 generations on · 132 of its ownK062822 Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc. · 2006
Descendant · 3 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007

Showing 5 of 298 descendants. See all descendants

Descendants cleared per year

2004high 44 (2025) · low 1 (2004)2026

Most influential descendants

Showing 5 of 298 · See all

K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · cites it directly297descendants
K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 2 generations on263descendants
K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 3 generations on192descendants
K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc. · 2006 · 2 generations on132descendants
K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 3 generations on129descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962354	Diomed 15, 30, 60 Surgical Diode Laser	Lifestream Int'L, Inc.	1996	—
0 (this device)	K013499	Diomed 15 Plus and Diomed 30PLUS Lasers	Diomed, Inc.	2001	—
+1	K041957	Evlt Kit and the D15PLUS and D30PLUS Diode Lasers	Diomed, Inc.	2004	1
+2	K072034	Diode Medical Laser Family, Models 4, 6, 30	Quanta System Spa	2007	—
+3	K083613	Quanta System Polysurge Diode Laser Family	Quanta System Spa	2008	—
+2	K062822	Vari-Lase Endovenous Laser Console, Model 7500	Vascular Solutions, Inc.	2006	—
+3	K070388	Profile Multi-Platform System	Sciton, Inc	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0
2007	3	0
2008	12	0
2009	4	0
2010	10	0
2011	6	0
2012	8	0
2013	10	0
2014	10	0
2015	14	0
2016	13	0
2017	11	0
2018	15	0
2019	10	0
2020	19	0
2021	13	0
2022	25	0
2023	17	0
2024	29	0
2025	44	0
2026	22	0

FIG. 1 — Lineage of K013499, 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

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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
*	K962354	Diomed 15, 30, 60 Surgical Diode Laser Summary page 1 …plus and Diomed 30plus Lasers Common/Usual Name: ~ Surgical Lasers Classification Name: Laser Surgical Instruments 3. PREDICATE DEVICES Diomed 15 and Diomed 30 Lasers -K962354 4. DEVICE DESCRIPTION The Diomed 15plus and Diomed 30plus Lasers are modified versions of the Diomed 15 and Diomed 30 lasers. A…	Lifestream Int'L, Inc.	1996	—

Also cleared against K962354: 1 other device →

What descends from it? (298)

See all 298

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

Number	Device	Applicant	Decided	Descendants
K041957	Evlt Kit and the D15PLUS and D30PLUS Diode Lasers	Diomed, Inc.	2004	297
K051996	Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30	Diomed, Ltd.	2005	89

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?

Its one ancestor has no recall.
Of its descendants, K041957 (Diomed, Inc., 2004) has gone furthest, with 297 descendants of its own.
1 other device also cites its predicate K962354.

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 Diomed l5plus and Diomed 30plus lasers are indicated for contact and non-contact use for the following soft tissue app]ina’rinns:

General Surgery

Ophthamology/Oculoplastic

Urology

Gastroenterology

Gynecology

Otorhinolaryngology

Pulmonary/T horacic

Dermatology/ Plastic Surgery

Neurosurgery (coagulation only)

Ortl)opeclic

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/K013499 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013499: Diomed 15 Plus and Diomed 30PLUS Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013499

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026