510(k) · Cleared

Cleared

HGM Illuminating Imaging Endocular Probe

K931784510(k) TraditionalCleared Mar 1, 1994326-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

Hgm, Inc. · HQF Laser, Ophthalmic

Cleared on Mar 1, 1994 after a 326-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.

Decided: Mar 1, 1994
Review: 326 days
Class: Class II
Product code: HQF
Recalls: None
Predicates: 0

15 later devices descend from it, 4 citing it directly.

This deviceK931784 HGM Illuminating Imaging Endocular ProbeHgm, Inc. · 1994
Descendant · cites it directly · 6 of its ownK031023 Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 2003 · Recalled
Descendant · 2 generations on · 4 of its ownK122997 23GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
Descendant · cites it directly · 4 of its ownK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
Descendant · 3 generations on · 2 of its ownK151604 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015
Descendant · 2 generations on · 1 of its ownK062336 Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2002high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 15 · See all

K031023Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 2003 · cites it directly6descendants
K12299723GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013 · 2 generations on4descendants
K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005 · cites it directly4descendants
K15160423ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015 · 3 generations on2descendants
K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K931784	HGM Illuminating Imaging Endocular Probe	Hgm, Inc.	1994	—
+1	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	K052526	Novus 3000 Laser System and Delivery Devices	Lumenis, Inc.	2005	—
+3	K151604	23ga Chandelier Illuminator, 25ga Chandelier Illuminator	Peregrine Surgical, Ltd.	2015	—
+2	K062336	Optimedica Laser Indirect Ophthalmoscope	Optimedica Corporation	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2005	1	0
2006	2	0
2009	1	0
2012	1	0
2013	2	0
2014	1	0
2015	2	0
2019	1	0
2024	1	0

FIG. 1 — Lineage of K931784, 1994–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (15)

See all 15

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031023	Peregrine Illuminating Laser Probe Model PD600.10	Peregrine Surgical, Ltd.	2003	6
K052526	Novus 3000 Laser System and Delivery Devices	Lumenis, Inc.	2005	4
K022228	Family of Iris Medical Endoprobe Handpieces	Iridex Corp	2002	1
K032704	Innovatech Illuminating Laser Probe, Model 420-30	Innovatech Surgical, Inc.	2003	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?

Of its descendants, K031023 (Peregrine Surgical, Ltd., 2003) has gone furthest, with 6 descendants of its own.

How does its category compare?

All HQF devices

HQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

https://510kreport.com/device/K931784 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931784: HGM Illuminating Imaging Endocular Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931784

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026