510(k) · Cleared
ClearedMAXReach Laser Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vortex Surgical, Inc. · HQB Photocoagulator And Accessories
Cleared on Dec 23, 2019 as substantially equivalent to K142830 (Ophthalmed, LLC, 2015) after a 166-day review. Its family tree reaches back 5 generations to 1987. 1 later device descends from it.
- Decided
- Dec 23, 2019
- Review
- 166 days
- Class
- Class II
- Product code
- HQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K870942 (1987). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK870942 MVS Fiberoptic LightpipeAdvanced Surgical Products, Inc. · 1987
- 4 generations backK982462 Fiber Optic Endoillumination ProbeMicrovision, Inc. · 1998
- 3 generations backK050807 20G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
- 2 generations backK121187 Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012
- 1 generation backK142830 Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015
- This deviceK191846 MAXReach Laser ProbeVortex Surgical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK220263 Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser…Vortex Surgical, Inc. · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical…Vortex Surgical, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K870942 | MVS Fiberoptic Lightpipe | Advanced Surgical Products, Inc. | 1987 | — |
| −4 | K982462 | Fiber Optic Endoillumination Probe | Microvision, Inc. | 1998 | — |
| −3 | K050807 | 20G Sma Laser Fiber, Model LF100 | Ophthalmed, LLC | 2005 | — |
| −2 | K121187 | Katalyst Laser Probes, Katalyst Illuminated Laser Probes | Katalyst Surgical, LLC | 2012 | — |
| −1 | K142830 | Ophthalmed Bending Laser Probes | Ophthalmed, LLC | 2015 | — |
| 0 (this device) | K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | 2019 | — |
| +1 | K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex… | Vortex Surgical, Inc. | 2022 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HQB? 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 HQB device
- #1 K220263 Vortex Surgical Laser Probes, Vortex Surgical…score 3.8 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K142830 | Ophthalmed Bending Laser ProbesSummary page 4…l MAXReach Laser Probe Single Use Endo Ocular Laser Probe Class I1 21 CFR 886.4690 Photocoagulator and Accessories HQB Ophthalmic Ophthalmed Directional Laser Probe, K142830 MAXReach Laser Probe is a sterile, single use medical device used for delivering laser endophotocoagulation into the posterior s… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical… | 2022 | 0 |
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 32 years and passes through 5 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K220263 (Vortex Surgical, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HQB devicesHQB Photocoagulator And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HQB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQB
221in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQB
7in 2025
MAUDE reports naming product code HQB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 57 | 0 | 3 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 3 | 221 | 28 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 2 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MAXReach Laser Probe is indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100nm. The MAXReach Laser Probe is compatible with the following lasers: Alcon Constellation/Pure Point Lasers, Iridex GL Laser and Ellex Solitaire Laser
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/K191846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191846: MAXReach Laser Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191846
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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