510(k) · Cleared

Cleared

Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser Probes, Katalyst Revolver Illuminated Probes

K140362510(k) TraditionalCleared Sep 15, 2014215-day reviewClass II21 CFR 886.4390

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Katalyst Surgical, LLC · HQF Laser, Ophthalmic

Cleared on Sep 15, 2014 as substantially equivalent to K121187 (Katalyst Surgical, LLC, 2012) after a 215-day review. Its family tree reaches back 4 generations to 1987.

Decided: Sep 15, 2014
Review: 215 days
Class: Class II
Product code: HQF
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K870942 (1987). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK870942 MVS Fiberoptic LightpipeAdvanced Surgical Products, Inc. · 1987
3 generations backK982462 Fiber Optic Endoillumination ProbeMicrovision, Inc. · 1998
2 generations backK050807 20G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
1 generation backK121187 Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012
This deviceK140362 Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser…Katalyst Surgical, LLC · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K870942	MVS Fiberoptic Lightpipe	Advanced Surgical Products, Inc.	1987	—
−3	K982462	Fiber Optic Endoillumination Probe	Microvision, Inc.	1998	—
−2	K050807	20G Sma Laser Fiber, Model LF100	Ophthalmed, LLC	2005	—
−1	K121187	Katalyst Laser Probes, Katalyst Illuminated Laser Probes	Katalyst Surgical, LLC	2012	—
0 (this device)	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

FIG. 1 — Lineage of K140362, 1987–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K121187	Katalyst Laser Probes, Katalyst Illuminated Laser Probes Summary page 5 …es: The Katalyst Revolver Laser Probe, Revolver Illuminated Laser Probe and Illuminated Probe were shown to be substantially equivalent to the previously cleared devices K121187- Katalyst Laser Probe and Illuminated Laser Probe. Performance Testing Summary: The testing for The Revolver Probes was conducte…	Katalyst Surgical, LLC	2012	—
†	K021696	20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25	Ophthalmed, LLC	2002	—
†	K050807	20G Sma Laser Fiber, Model LF100	Ophthalmed, LLC	2005	—

Also cleared against K121187: 2 other devices →

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 27 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
1 of the 7 ancestors has a recall of any class.
2 other devices also cite its predicate K121187.

How does its category compare?

All HQF devices

HQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · HQF

3in 2025

2007high 7 (2009) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQF

264in 2025

2007high 295 (2015) · low 28 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HQF

1in 2025

2007high 5 (2011) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQF

106in 2025

2007high 111 (2022) · low 26 (2011)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?

Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes are intended for use in

vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments.

The Revolver Laser Probes can only be used with a medical laser at operating wavelengths of 500nm to 900nm. The Revolver assemblies containing illumination should only be used with the light wavelength range of 425nm to 700nm.

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/K140362 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140362: Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser Probes, Katalyst Revolver Illuminated Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140362

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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