510(k) · Cleared
ClearedUni-Laser 425P Diode Laser System & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medart Corp. · GEX Powered Laser Surgical Instrument
Cleared on Jul 29, 1999 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 134 later devices descend from it.
- Decided
- Jul 29, 1999
- Review
- 76 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
134 later devices descend from it, 1 citing it directly.
- This deviceK991659 Uni-Laser 425P Diode Laser System & AccessoriesMedart Corp. · 1999
- Descendant · cites it directly · 133 of its ownK033237 Vascular Solutions Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc. · 2003
- 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
- Descendant · 4 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 4 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Showing 5 of 134 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 134 · See all- K033237Vascular Solutions Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc. · 2003 · cites it directly133descendants
- K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc. · 2006 · 2 generations on132descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 3 generations on129descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 4 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 4 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991659 | Uni-Laser 425P Diode Laser System & Accessories | Medart Corp. | 1999 | — |
| +1 | K033237 | Vascular Solutions Vari-Lase Endovenous Laser Console | Vascular Solutions, Inc. | 2003 | — |
| +2 | K062822 | Vari-Lase Endovenous Laser Console, Model 7500 | Vascular Solutions, Inc. | 2006 | — |
| +3 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +4 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +4 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 9 | 0 |
| 2019 | 7 | 0 |
| 2020 | 11 | 0 |
| 2021 | 9 | 0 |
| 2022 | 18 | 0 |
| 2023 | 9 | 0 |
| 2024 | 14 | 0 |
| 2025 | 15 | 0 |
| 2026 | 11 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (134)
See all 1341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033237 | Vascular Solutions Vari-Lase Endovenous Laser Console | 2003 | 133 |
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, K033237 (Vascular Solutions, Inc., 2003) has gone furthest, with 133 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 Uni-laser 425P Diode Laser System and accessories arc indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissuc. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include: Dermatology and Plastic Surgery for…
Read the full statement (119 words)
The Uni-laser 425P Diode Laser System and accessories arc indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissuc. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:
Dermatology and Plastic Surgery for
Photocoagulation of dermatological vascular lesions
Photothermolysis of blood vessels (treatment of facial and leg veins)
Removal of pigmented lesions
Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), and oral surgery;
Ear Nose & Throat; Otorhinolaryngology: Neurosurgery (coagulation only);
Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery;
Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991659 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991659: Uni-Laser 425P Diode Laser System & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991659
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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