510(k) · Cleared
ClearedDC-3300 Laser Diode Photocoagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek, Inc. · HQF Laser, Ophthalmic
Cleared on Feb 11, 2002 as substantially equivalent to K903639 (Nidek, Inc., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1991. 70 later devices descend from it.
- Decided
- Feb 11, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903639 (1991). 2 ancestors in all. 70 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK903639 Nidek DC-3000 Diode Laser PhotocoagulatorNidek, Inc. · 1991
- This deviceK013760 DC-3300 Laser Diode PhotocoagulatorNidek, Inc. · 2002
- Descendant · cites it directly · 69 of its ownK020374 Oculight SL/SLXIridex Corp · 2002
- Descendant · 2 generations on · 29 of its ownK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- Descendant · 3 generations on · 23 of its ownK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- Descendant · 4 generations on · 22 of its ownK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- Descendant · 2 generations on · 21 of its ownK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K020374Oculight SL/SLXIridex Corp · 2002 · cites it directly69descendants
- K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005 · 2 generations on29descendants
- K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009 · 3 generations on23descendants
- K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009 · 4 generations on22descendants
- K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903639 | Nidek DC-3000 Diode Laser Photocoagulator | Nidek, Inc. | 1991 | — |
| 0 (this device) | K013760 | DC-3300 Laser Diode Photocoagulator | Nidek, Inc. | 2002 | — |
| +1 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| +2 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| +3 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| +4 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| +2 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 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 |
|---|---|---|---|
| * | K903639 | Nidek DC-3000 Diode Laser PhotocoagulatorSummary page 1…ssification Name: Ophthalmic Laser 21 CFR 886.4390 HQF 14.3 IDENTIFICATION OF PREDICATE DEVICES Company Device 510(k) No. Date Cleared Nidek, Inc. DC-3000 Laser Diode K903639 02/04/1991 Photocoagulator Iriderm Iris OcuLight SLx K913430 11/15/1991 Iriderm Iris OcuLight Diode Laser =~ K912918 08/23/1991… | 1991 |
| * | K913430 | Iris Oculight (R) SLXSummary page 1…DENTIFICATION OF PREDICATE DEVICES Company Device 510(k) No. Date Cleared Nidek, Inc. DC-3000 Laser Diode K903639 02/04/1991 Photocoagulator Iriderm Iris OcuLight SLx K913430 11/15/1991 Iriderm Iris OcuLight Diode Laser =~ K912918 08/23/1991 With Slit Lamp Adapter Nidek DC3300 Laser Di… | 1991 |
| † | K912918 | Iris Oculight Diode Laser Adding Slit Lamp Adapter | 1991 |
What descends from it? (70)
See all 704 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?
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Nidek DC-3300 Laser Diode Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The DC-3300 is used in combination with various delivery systems, such as slit lamps, binocular indirect ophthalmoscopes, endoprobes, and transscleral probes.
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/K013760 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013760: DC-3300 Laser Diode Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013760
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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