510(k) · Cleared
ClearedKatalyst Laser Probes, Katalyst Illuminated Laser Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Katalyst Surgical, LLC · HQF Laser, Ophthalmic
Cleared on Sep 17, 2012 as substantially equivalent to K021696 (Ophthalmed, LLC, 2002) and 1 other predicate after a 151-day review. Its family tree reaches back 3 generations to 1987. 5 later devices descend from it.
- Decided
- Sep 17, 2012
- Review
- 151 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K870942 (1987). 6 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK870942 MVS Fiberoptic LightpipeAdvanced Surgical Products, Inc. · 1987
- 2 generations backK982462 Fiber Optic Endoillumination ProbeMicrovision, Inc. · 1998
- 1 generation backK050807 20G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
- This deviceK121187 Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012
- Descendant · cites it directly · 2 of its ownK142830 Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK191846 MAXReach Laser ProbeVortex Surgical, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK220263 Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser…Vortex Surgical, Inc. · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK182646 Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019
- Descendant · cites it directly · 0 of its ownK140362 Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser…Katalyst Surgical, LLC · 2014
Most influential descendants
Showing 5 of 5 · See all- K142830Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015 · cites it directly2descendants
- K191846MAXReach Laser ProbeVortex Surgical, Inc. · 2019 · 2 generations on1descendant
- K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical…Vortex Surgical, Inc. · 2022 · 3 generations on0descendants
- K182646Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019 · cites it directly0descendants
- K140362Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser Probes, Katalyst…Katalyst Surgical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870942 | MVS Fiberoptic Lightpipe | Advanced Surgical Products, Inc. | 1987 | — |
| −2 | K982462 | Fiber Optic Endoillumination Probe | Microvision, Inc. | 1998 | — |
| −1 | K050807 | 20G Sma Laser Fiber, Model LF100 | Ophthalmed, LLC | 2005 | — |
| 0 (this device) | K121187 | Katalyst Laser Probes, Katalyst Illuminated Laser Probes | Katalyst Surgical, LLC | 2012 | — |
| +1 | K142830 | Ophthalmed Bending Laser Probes | Ophthalmed, LLC | 2015 | — |
| +2 | K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | 2019 | — |
| +3 | K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex… | Vortex Surgical, Inc. | 2022 | 3 |
| +1 | K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | 2019 | — |
| +1 | K140362 | Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser Probes… | Katalyst Surgical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K021696 | 20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25Summary page 2…the illumination fiber. Predicate Devices: The Katalyst Illuminated Laser Probe was shown to be substantially equivalent to the previously cleared devices (K050807 and K02 1696). /V/27/67I- Subst… | 2002 |
| * | K050807 | 20G Sma Laser Fiber, Model LF100Summary page 2…er fiber and the illumination fiber. Predicate Devices: The Katalyst Illuminated Laser Probe was shown to be substantially equivalent to the previously cleared devices (K050807 and K02 1696). /V/2… | 2005 |
What descends from it? (5)
3 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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K142830 (Ophthalmed, LLC, 2015) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K021696.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
For use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelength of SO0nm to 900nm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121187: Katalyst Laser Probes, Katalyst Illuminated Laser Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121187
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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