510(k) · Cleared

Cleared

Peregrine Straight Laser Probe, Model PD6000.00

K024061510(k) TraditionalCleared Mar 7, 200388-day reviewClass II21 CFR 878.4810

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

Peregrine Surgical, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Mar 7, 2003 as substantially equivalent to K954307 (Gamp & Assoc., 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1995. 11 later devices descend from it.

Decided: Mar 7, 2003
Review: 88 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K954307 (1995). 2 ancestors in all. 11 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK954307 Gamp & Assoc. Disposable Endoocular Laser ProbeGamp & Assoc. · 1995
This deviceK024061 Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 2003
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 · 3 generations on · 2 of its ownK151604 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015
Descendant · cites it directly · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
Descendant · 2 generations on · 0 of its ownK250501 System SophiThis AG · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003high 3 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · 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
K15160423ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015 · 3 generations on2descendants
K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · cites it directly1descendant
K250501System SophiThis AG · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954307	Gamp & Assoc. Disposable Endoocular Laser Probe	Gamp & Assoc.	1995	—
0 (this device)	K024061	Peregrine Straight Laser Probe, Model PD6000.00	Peregrine Surgical, Ltd.	2003	—
+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	—
+3	K151604	23ga Chandelier Illuminator, 25ga Chandelier Illuminator	Peregrine Surgical, Ltd.	2015	—
+1	K213467	EVA NEXUS Ophthalmic Surgical System	D.O.R.C. Dutch Ophthalmic Research Center (International)	2022	6
+2	K250501	System Sophi	This AG	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	3	0
2013	2	0
2014	1	0
2015	1	0
2019	1	0
2022	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K024061, 1995–2025Source: 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 GEX? 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 GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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	Applicant	Decided	Recalls
*	K954307	Gamp & Assoc. Disposable Endoocular Laser Probe Summary page 2 …Endo Illuminator 25ga Product PD600.00 Endoocular Laser Probe Farnilied under 510K K980797 Peregrine Straight Laser Probe 510K K954307 Manufactured by Peregrine Manufactured by Garnp & Assoc. Light transmission fo…	Gamp & Assoc.	1995	—
*	K980797	Peregrine Fiber Optic Multi-Function Manipulator Summary page 2 …for 510K Substantial Equivalence to: B&L Endo Illuminator 25ga Product PD600.00 Endoocular Laser Probe Farnilied under 510K K980797 Peregrine Straight Laser Probe 510K K954307 Manufactured by Peregrine…	Peregrine Surgical, Ltd.	1998	—

Also cleared against K954307: 2 other devices →

What descends from it? (11)

See all 11

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
K213467	EVA NEXUS Ophthalmic Surgical System	D.O.R.C. Dutch Ophthalmic Research Center (International)	2022	1
K032704	Innovatech Illuminating Laser Probe, Model 420-30	Innovatech Surgical, Inc.	2003	0
K032703	Innovatech Straight Laser Probe, Model 420-10	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?

None of the 2 ancestors has a recall.
Of its descendants, K031023 (Peregrine Surgical, Ltd., 2003) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K954307.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

For photocoagulation during ophthalmic surgery. This device delivers laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024061 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024061: Peregrine Straight Laser Probe, Model PD6000.00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024061

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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