510(k) · Cleared

Cleared

Supra 577.Y Laser

K091581510(k) TraditionalCleared Jun 16, 200914-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 Jun 16, 2009 as substantially equivalent to K071687 (Iridex Corp, 2008) after a 14-day review. Its family tree reaches back 1 generation to 2008. 16 later devices descend from it.

Decided: Jun 16, 2009
Review: 14 days
Class: Class II
Product code: HQF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K071687 (2008). 16 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK071687 Famili of Iridex IQ Laser SystemsIridex Corp · 2008
This deviceK091581 Supra 577.Y LaserQuantel Medical · 2009
Descendant · cites it directly · 15 of its ownK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
Descendant · 2 generations on · 6 of its ownK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
Descendant · 2 generations on · 5 of its ownK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
Descendant · cites it directly · 2 of its ownK141851 Navilas Laser SystemOd-Os GmbH · 2015
Descendant · 3 generations on · 1 of its ownK223132 Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and…Iridex Corporation · 2022

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2011high 3 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 16 · See all

K111108Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011 · cites it directly15descendants
K121475Txcell Scanning Laser Delivery SystemIridex Corp · 2012 · 2 generations on6descendants
K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · 2 generations on5descendants
K141851Navilas Laser SystemOd-Os GmbH · 2015 · cites it directly2descendants
K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation · 2022 · 3 generations on1descendant

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)	K091581	Supra 577.Y Laser	Quantel Medical	2009	—
+1	K111108	Pascal Streamline 577 (with Accessories)	Topcon Medical Laser Systems, Inc.	2011	—
+2	K121475	Txcell Scanning Laser Delivery System	Iridex Corp	2012	—
+2	K123542	Pascal Synthesis (532NM/577NM) Opthalmic Laser	Topcon Medical Laser Systems, Inc.	2013	1
+1	K141851	Navilas Laser System	Od-Os GmbH	2015	—
+3	K223132	Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)	Iridex Corporation	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	3	0
2013	2	0
2015	2	0
2016	1	0
2017	3	0
2018	1	0
2019	1	0
2022	1	0
2025	1	0

FIG. 1 — Lineage of K091581, 2008–2025Source: 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 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? (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 1 …Name: Product Code: HQF ' Panel: 86 III. Predicate Device IRIDEX IQ 577 Laser (K071687) IV. Product Description…	Iridex Corp	2008	—

Also cleared against K071687: 12 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K111108	Pascal Streamline 577 (with Accessories)	Topcon Medical Laser Systems, Inc.	2011	15
K141851	Navilas Laser System	Od-Os GmbH	2015	2

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, K111108 (Topcon Medical Laser Systems, Inc., 2011) has gone furthest, with 15 descendants of its own.
12 other devices also cite its predicate K071687.

How does its category compare?

All HQF devices

HQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 Supra 577.Y Laser system and accessories that are used with it to deliver laser energy in either CW pulse, MicroPulse or Long Pulse mode in the medical specialties of ophthalmology as follows: Ophthalmology: Indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina. and…

Read the full statement (103 words)

The Supra 577.Y Laser system and accessories that are used with it to deliver laser energy in either CW pulse, MicroPulse or Long Pulse mode in the medical specialties of ophthalmology as follows:

Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:

Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina. and choroids. including:

1. Proliferative and nonproliferative diabetic retinopathy;

2. choroidal neovascularization;

3. branch retinal vein occlusion;

4. age-related macular degeneration;

5. retinal tears and detachments;

6. retinopathy of prematurity;

Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091581 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091581: Supra 577.Y Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091581

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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