510(k) · Cleared
ClearedVitreq disposable laser probes, light fibers and Chandelier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VitreQ BV · HQB Photocoagulator And Accessories
Cleared on May 1, 2019 as substantially equivalent to K121187 (Katalyst Surgical, LLC, 2012) and 1 other predicate after a 219-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- May 1, 2019
- Review
- 219 days
- Class
- Class II
- Product code
- HQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954307 (1995). 15 ancestors in all, the oldest K870942 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK954307 Gamp & Assoc. Disposable Endoocular Laser ProbeGamp & Assoc. · 1995
- 4 generations backK024061 Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 2003
- 3 generations backK031023 Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 2003 · Recalled
- 2 generations backK122997 23GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
- 1 generation backK151604 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015
- This deviceK182646 Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954307 | Gamp & Assoc. Disposable Endoocular Laser Probe | Gamp & Assoc. | 1995 | — |
| −4 | K024061 | Peregrine Straight Laser Probe, Model PD6000.00 | Peregrine Surgical, Ltd. | 2003 | — |
| −3 | K031023 | Peregrine Illuminating Laser Probe Model PD600.10 | Peregrine Surgical, Ltd. | 2003 | 1 |
| −2 | K122997 | 23GA Curved Illuminating Laser Probe | Peregrine Surgical, Ltd. | 2013 | — |
| −1 | K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical, Ltd. | 2015 | — |
| 0 (this device) | K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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.
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? (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 |
|---|---|---|---|
| * | K121187 | Katalyst Laser Probes, Katalyst Illuminated Laser ProbesSummary page 4…vice is substantially equivalent to the predicate device cited in the table below: 510(k) Applicant Device Name Product Code Claim K121187 Katalyst Katalyst Laser Probes & HQF, HQB, Predicate Surgical, LLC Illuminated Laser Pro… | 2012 |
| * | K151604 | 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorSummary page 4…Surgical, LLC Illuminated Laser Probes MPA Device (primary) K151604 Peregrine Peregrine 23 ga and 25 ga MPA Predicate Surgical Ltd. Adjustable Chandelier… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 2 other devices also cite its predicate K121187.
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?
VitreQ Disposable Laser Probes, 90° Directional Laser Probes and 90° Directional Illuminated Laser Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelengths of 500nm to 900nm.
The 90° Directional Illuminated Laser Probes, Light Fibers and Chandelier are for illumination during ophthalmic surgery and should only be used with the light wavelength range of 425nm to 700nm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182646: Vitreq disposable laser probes, light fibers and Chandelier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182646
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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