510(k) · Cleared
ClearedCeralas D10-60 810NM Diode Laser, Modelceralas Dio-60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolitec, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 12, 2002 after a 90-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 12, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK020835 Ceralas D10-60 810NM Diode Laser, Modelceralas Dio-60Biolitec, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK023624 SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK030654 Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 0 of its ownK032805 Modification to Vascular Solutions Vari-Lase Endovenous Laser…Vascular Solutions, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K023624SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc. · 2003 · cites it directly2descendants
- K030654Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2003 · 2 generations on1descendant
- K032805Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2003 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020835 | Ceralas D10-60 810NM Diode Laser, Modelceralas Dio-60 | Biolitec, Inc. | 2002 | — |
| +1 | K023624 | SLT Venous Fiber Delivery Systems, Model… | Surgical Laser Technologies, Inc. | 2003 | — |
| +2 | K030654 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions, Inc. | 2003 | 1 |
| +3 | K032805 | Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 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? (2)
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 810nm Surgical Laser Named without a submission number | |
| * | — | Biolitec Ceralas D10-60 810nm Diode Laser Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023624 | SLT Venous Fiber Delivery Systems, Model… | 2003 | 2 |
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, K023624 (Surgical Laser Technologies, Inc., 2003) has gone furthest, with 2 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?
In addition to the Ceralas D 10-60 810 nm Diode Laser System's previously-cleared indications, this device is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
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/K020835 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020835: Ceralas D10-60 810NM Diode Laser, Modelceralas Dio-60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020835
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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