510(k) · Cleared
Recalled · Class II · 2025Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
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 Nov 3, 2022 as substantially equivalent to K191846 (Vortex Surgical, Inc., 2019) after a 276-day review. Its family tree reaches back 6 generations to 1987. It has been recalled 3 times.
- Decided
- Nov 3, 2022
- Review
- 276 days
- Class
- Class II
- Product code
- HQB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 6 generations to K870942 (1987). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK870942 MVS Fiberoptic LightpipeAdvanced Surgical Products, Inc. · 1987
- 5 generations backK982462 Fiber Optic Endoillumination ProbeMicrovision, Inc. · 1998
- 4 generations backK050807 20G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
- 3 generations backK121187 Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012
- 2 generations backK142830 Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015
- 1 generation backK191846 MAXReach Laser ProbeVortex Surgical, Inc. · 2019
- This deviceK220263 Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser…Vortex Surgical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K870942 | MVS Fiberoptic Lightpipe | Advanced Surgical Products, Inc. | 1987 | — |
| −5 | K982462 | Fiber Optic Endoillumination Probe | Microvision, Inc. | 1998 | — |
| −4 | K050807 | 20G Sma Laser Fiber, Model LF100 | Ophthalmed, LLC | 2005 | — |
| −3 | K121187 | Katalyst Laser Probes, Katalyst Illuminated Laser Probes | Katalyst Surgical, LLC | 2012 | — |
| −2 | K142830 | Ophthalmed Bending Laser Probes | Ophthalmed, LLC | 2015 | — |
| −1 | K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | 2019 | — |
| 0 (this device) | K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex… | Vortex Surgical, Inc. | 2022 | — |
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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K191846 | MAXReach Laser ProbeSummary page 4…Laser Probe Common Name: Ophthalmic Laser Vortex Branded Name: Direct Flex Laser Probe 510(k) Number: K191846 Regulatory class: II Product Codes: HQB Regulation Number: 21 CF… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2025 | Class II | Z-1246-2026 | Employee error | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. |
| Dec 16, 2025 | Class II | Z-1245-2026 | Employee error | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. |
| Nov 19, 2025 | Class II | Z-1004-2026 | Component design/selection | Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All HQB devicesHQB Photocoagulator And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Vortex Surgical Laser Probes and Illuminated Laser Probes are indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100nm. Vortex Surgical Illuminated Laser Probes, Endoilluminator, and Chandelier are indicated for illumination during vitreoretinal surgery with visible light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220263: Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220263
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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