510(k) · Cleared

Cleared

IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)

K143154510(k) SpecialCleared Jan 2, 201560-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

Iridex Corporation · GEX Powered Laser Surgical Instrument

Cleared on Jan 2, 2015 as substantially equivalent to K071687 (Iridex Corp, 2008) after a 60-day review. Its family tree reaches back 1 generation to 2008. 3 later devices descend from it.

Decided: Jan 2, 2015
Review: 60 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K071687 (2008). 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK071687 Famili of Iridex IQ Laser SystemsIridex Corp · 2008
This deviceK143154 IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)Iridex Corporation · 2015
Descendant · cites it directly · 1 of its ownK162416 IRIDEX Cyclo G6 Laser System, G-Probe IlluminateIridex Corporation · 2016
Descendant · cites it directly · 0 of its ownK213592 Iridex 810 LaserIridex Corporation · 2022
Descendant · cites it directly · 0 of its ownK163632 Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLC · 2017

Most influential descendants

Showing 3 of 3 · See all

K162416IRIDEX Cyclo G6 Laser System, G-Probe IlluminateIridex Corporation · 2016 · cites it directly1descendant
K213592Iridex 810 LaserIridex Corporation · 2022 · cites it directly0descendants
K163632Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLC · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K071687	Famili of Iridex IQ Laser Systems	Iridex Corp	2008	—
0 (this device)	K143154	IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)	Iridex Corporation	2015	—
+1	K162416	IRIDEX Cyclo G6 Laser System, G-Probe Illuminate	Iridex Corporation	2016	—
+1	K213592	Iridex 810 Laser	Iridex Corporation	2022	—
+1	K163632	Katalyst Cyclophotocoagulation Probe	Katalyst Surgical, LLC	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	1	0
2022	1	0

FIG. 1 — Lineage of K143154, 2008–2022Source: 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

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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
*	K071687	Famili of Iridex IQ Laser Systems Summary page 4 …Cyclo G6 Primary Classification Name(s): Electrosurgical cutting and coagulation device and accessories III. Predicate Devices  K071687 – Family of Iridex IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, IQ 810) Premarket Notificatio…	Iridex Corp	2008	—

Also cleared against K071687: 12 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K162416	IRIDEX Cyclo G6 Laser System, G-Probe Illuminate	Iridex Corporation	2016	1
K213592	Iridex 810 Laser	Iridex Corporation	2022	0
K163632	Katalyst Cyclophotocoagulation Probe	Katalyst Surgical, LLC	2017	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?

Its one ancestor has no recall.
Of its descendants, K162416 (Iridex Corporation, 2016) has gone furthest, with 1 descendant of its own.
12 other devices also cite its predicate K071687.

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. 2015, this device’s year, is highlighted.

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?

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical…

Read the full statement (168 words)

810nm (IRIDEX Cyclo G6 Laser System)

Ophthalmology:

The IRIDEX® Cyclo G6 Laser System and Probe Delivery Devices (G-Probe & MicroPulse P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse™ (µP) treatment mode and indicated for the treatment of Glaucoma:

MicroPulse P3 Device: For the treatment of Glaucoma including: Primary Open-Angle, Closed-Angle, Refractory. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. CW/µP: µP.

G-Probe: For the treatment of Glaucoma including: Primary Open-Angle, Closed-Angle, Refractory. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. CW/µP: CW.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143154 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143154: IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143154

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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