510(k) · Cleared

Cleared

Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1

K060905510(k) TraditionalCleared May 31, 200658-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 Corp · GEX Powered Laser Surgical Instrument

Cleared on May 31, 2006 as substantially equivalent to K990174 (Fisma, Inc., 1999) and 3 other predicates after a 58-day review. Its family tree reaches back 3 generations to 1991.

Decided: May 31, 2006
Review: 58 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K904627 (1991). 23 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
2 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
1 generation backK980389 Megabeam Reusable Fiber Optic Handpiece and NeedlesCeram Optec, Inc. · 1998
This deviceK060905 Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1Iridex Corp · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K904627	Centauri Yag Laser Syst, Ear, Nose , Throat	Pfizer Laser Systems	1991	—
−2	K960032	Coherent Versapulse Aesthetic Surgical Lasers	Coherent Medical Group	1996	—
−1	K980389	Megabeam Reusable Fiber Optic Handpiece and Needles	Ceram Optec, Inc.	1998	—
0 (this device)	K060905	Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1	Iridex Corp	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	2	0
1992	1	0
1993	2	0
1994	8	0
1995	6	0
1999	1	0

FIG. 1 — Lineage of K060905, 1991–2006Source: 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? (4)

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
*	K990174	Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite… Summary page 1 …robe Primary Classification Names: Accessory for, Laser Powered Surgical Instruments Ill. Predicate Devices * Lumenis EndoOto Probe (K990174) * CeramOpiec MegaBeam Fiber Optic Delivery System (K943445 & 980389) * Biolitec Megabeam Endo-ENT Probe(K952…	Fisma, Inc.	1999	—
*	K943445	Megabeam Fiber Optic Delivery System Summary page 1 …Laser Powered Surgical Instruments Ill. Predicate Devices * Lumenis EndoOto Probe (K990174) * CeramOpiec MegaBeam Fiber Optic Delivery System (K943445 & 980389) * Biolitec Megabeam Endo-ENT Probe(K952772) IV. Product Description The IRIDEX OtoProbe is…	Ceram Optec, Inc.	1994	—
*	K980389	Megabeam Reusable Fiber Optic Handpiece and Needles Summary page 1 …red Surgical Instruments Ill. Predicate Devices * Lumenis EndoOto Probe (K990174) * CeramOpiec MegaBeam Fiber Optic Delivery System (K943445 & 980389) * Biolitec Megabeam Endo-ENT Probe(K952772) IV. Product Description The IRIDEX OtoProbe is comprised…	Ceram Optec, Inc.	1998	—
*	K952772	Megabeam Endo-Ent Probe Summary page 1 …s * Lumenis EndoOto Probe (K990174) * CeramOpiec MegaBeam Fiber Optic Delivery System (K943445 & 980389) * Biolitec Megabeam Endo-ENT Probe(K952772) IV. Product Description The IRIDEX OtoProbe is comprised of the following main components: * A glass…	Ceram Optec, Inc.	1995	—

Also cleared against K990174: 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 15 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
None of the 23 ancestors has a recall.
2 other devices also cite its predicate K990174.

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?

The IRIDEX OtoProbe is intended for use in surgical procedures for use in incision, excision, coagulation, and vaporization of soft and fibrous tissue including osseous tissue in the medical specialty of ENT surgery. The IRIDEX OtoProbe is cleared for use for the particular indications of the compatible laser system to which it is attached.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060905 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060905: Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060905

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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