510(k) · Cleared

Cleared

Diopexy Probe

K960522510(k) TraditionalCleared Jul 19, 1996164-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

Cleared on Jul 19, 1996 as substantially equivalent to K872362 (Frigitronics of Connecticut, Inc., 1987) and 3 other predicates after a 164-day review. Its family tree reaches back 1 generation to 1987.

Decided: Jul 19, 1996
Review: 164 days
Class: Class II
Product code: HQF
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K872362 (1987). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK872362 Frigitronics Acc-1000 Capsule CutterFrigitronics of Connecticut, Inc. · 1987
This deviceK960522 Diopexy ProbeIriderm Div. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K872362	Frigitronics Acc-1000 Capsule Cutter	Frigitronics of Connecticut, Inc.	1987	—
0 (this device)	K960522	Diopexy Probe	Iriderm Div.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	1	0
1994	1	0

FIG. 1 — Lineage of K960522, 1987–1996Source: 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K872362	Frigitronics Acc-1000 Capsule Cutter Summary page 1 …icate devices currently marketed: (1) the MIRA MD-1000 Microdiathermy System (pre-amendment), (2) the CooperSurgical Frigitronics CE-2000 Ophthalmic Cryosurgical System (K872362, K891282), (3) the IRIS Medical Laser Indirect Ophthalmoscope delivery device (K903288), and (4) the IRIS Medical G-Probe (K91523…	Frigitronics of Connecticut, Inc.	1987	—
*	K891282	Mic-100 with Cryoprobes Summary page 1 …ices currently marketed: (1) the MIRA MD-1000 Microdiathermy System (pre-amendment), (2) the CooperSurgical Frigitronics CE-2000 Ophthalmic Cryosurgical System (K872362, K891282), (3) the IRIS Medical Laser Indirect Ophthalmoscope delivery device (K903288), and (4) the IRIS Medical G-Probe (K915236). Page…	Frigitronics of Connecticut, Inc.	1989	—
*	K903288	Iris Oculight SL Diode Laser Photocoag/Modified Summary page 1 …ment), (2) the CooperSurgical Frigitronics CE-2000 Ophthalmic Cryosurgical System (K872362, K891282), (3) the IRIS Medical Laser Indirect Ophthalmoscope delivery device (K903288), and (4) the IRIS Medical G-Probe (K915236). Page \| Intended Use The intended use of this device is transscler…	Iriderm Div.	1990	—
*	K915236	Iris G-Probe Summary page 1 …E-2000 Ophthalmic Cryosurgical System (K872362, K891282), (3) the IRIS Medical Laser Indirect Ophthalmoscope delivery device (K903288), and (4) the IRIS Medical G-Probe (K915236). Page \| Intended Use The intended use of this device is transscleral retinal photocoagulation (TSRPC) for reti…	Iriderm Div.	1994	—
*	—	MIRA MD-1000 Microdiathermy System Named without a submission number			—

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?

None of the 4 ancestors has a recall.

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	—

What is it indicated for?

The intended use of this device is transscleral retinal photocoagulation (TSRPC) for retinopexy.

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/K960522 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960522: Diopexy Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960522

Report an extraction error

Are you the manufacturer?

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