510(k) · Cleared
ClearedDiomed 15, 30, 60 Surgical Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifestream Int'L, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 11, 1996 after an 85-day review. The FDA summary names its predicate without a number. 300 later devices descend from it.
- Decided
- Sep 11, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
300 later devices descend from it, 2 citing it directly.
- This deviceK962354 Diomed 15, 30, 60 Surgical Diode LaserLifestream Int'L, Inc. · 1996
- Descendant · cites it directly · 298 of its ownK013499 Diomed 15 Plus and Diomed 30PLUS LasersDiomed, Inc. · 2001
- Descendant · 2 generations on · 297 of its ownK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · 4 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 3 generations on · 132 of its ownK062822 Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc. · 2006
Showing 5 of 300 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 300 · See all- K013499Diomed 15 Plus and Diomed 30PLUS LasersDiomed, Inc. · 2001 · cites it directly298descendants
- K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · 2 generations on297descendants
- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 3 generations on263descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 4 generations on192descendants
- K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc. · 2006 · 3 generations on132descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962354 | Diomed 15, 30, 60 Surgical Diode Laser | Lifestream Int'L, Inc. | 1996 | — |
| +1 | K013499 | Diomed 15 Plus and Diomed 30PLUS Lasers | Diomed, Inc. | 2001 | — |
| +2 | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | 1 |
| +3 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +4 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +3 | K062822 | Vari-Lase Endovenous Laser Console, Model 7500 | Vascular Solutions, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 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 |
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
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 | Decided |
|---|---|---|---|
| * | — | Diomed 25 Surgical Diode Laser Named without a submission number |
What descends from it? (300)
See all 3002 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K013499 (Diomed, Inc., 2001) has gone furthest, with 298 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 Surgical Diode Laser is intended for use in delivering 15, 30, or 60 Watts of continuous wave radiation to a flexible optical fiber, for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures.
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/K962354 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962354: Diomed 15, 30, 60 Surgical Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962354
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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