510(k) · Cleared
ClearedKatalyst Cyclophotocoagulation Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Katalyst Surgical, LLC · LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Cleared on Jun 15, 2017 as substantially equivalent to K143154 (Iridex Corporation, 2015) after a 175-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Jun 15, 2017
- Review
- 175 days
- Class
- Class II
- Product code
- LQJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071687 (2008). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LQJ? 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 |
|---|---|---|---|
| * | K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)Summary page 5…redicate Devices: The Katalyst Cyclophotocoagulation Probe was shown to be substantially equivalent to the previously cleared device, Iridex G-Probe approved within 510k K143154. Substantial Equivalence: Clinical Testing was not required to prove substantial equivalence. Bench testing performed between th… | 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 9 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K143154.
How does its category compare?
All LQJ devicesLQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LQJ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · LQJ
Too few LQJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LQJ
No recall names LQJ since 2007.
Adverse event reports per year · LQJ
1in 2011
MAUDE reports naming product code LQJ, 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 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Katalyst Cyclophotocoagulation Probe is intended, when used with an infrared laser, for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process.
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/K163632 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163632: Katalyst Cyclophotocoagulation Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163632
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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