510(k) · Cleared
ClearedIridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corporation · HQF Laser, Ophthalmic
Cleared on Nov 9, 2022 as substantially equivalent to K123542 (Topcon Medical Laser Systems, Inc., 2013) after a 37-day review. Its family tree reaches back 10 generations to 1989. 1 later device descends from it.
- Decided
- Nov 9, 2022
- Review
- 37 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894841 (1989). 31 ancestors in all, the oldest K812219 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 6 generations between
- 3 generations backK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- 2 generations backK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- 1 generation backK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
- This deviceK223132 Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and…Iridex Corporation · 2022
- Descendant · cites it directly · 0 of its ownK251772 Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
Show all 10 generations
- Root · 10 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 9 generations backK960971 Oculight GLIriderm Div. · 1996
- 8 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 7 generations backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- 6 generations backK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- 5 generations backK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- 4 generations backK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
- 3 generations backK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- 2 generations backK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- 1 generation backK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
- This deviceK223132 Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and…Iridex Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −9 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −8 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −7 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| −6 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| −5 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| −4 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
| −3 | K111108 | Pascal Streamline 577 (with Accessories) | Topcon Medical Laser Systems, Inc. | 2011 | — |
| −2 | K121475 | Txcell Scanning Laser Delivery System | Iridex Corp | 2012 | — |
| −1 | K123542 | Pascal Synthesis (532NM/577NM) Opthalmic Laser | Topcon Medical Laser Systems, Inc. | 2013 | 1 |
| 0 (this device) | K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | 2022 | — |
| +1 | K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K123542 | Pascal Synthesis (532NM/577NM) Opthalmic LaserSummary page 5…edicate Device Laser Console Company: Iridex Corporation Device: PASCAL® Synthesis™ Ophthalmic Scanning Laser System (K123542) 510(k) SUMMARY; K223132 (continued) Intended Use A laser system console with an integrat… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251772 | Navilas Laser System 577sl (156691) | 2025 | 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?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K251772 (Od-Os GmbH, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123542.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 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?
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: (532nm) • proliferative and non-proliferative diabetic retinopathy • macular edema • choroidal neovascularization…
Read the full statement (129 words)
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
(532nm)
• proliferative and non-proliferative diabetic retinopathy
• macular edema
• choroidal neovascularization associated with wet age-related macular degeneration
• age-related macular degeneration
• lattice degeneration
• retinal tears and detachments
(577nm)
• proliferative and non-proliferative diabetic retinopathy
• macular edema
• choroidal neovascularization associated with wet age-related macular degeneration
• age-related macular degeneration
• lattice degeneration
• retinal tears and detachments
Intended for use in the treatment of ocular pathology in the anterior segment including:
(532 nm and 577nm)
• iridotomy
• trabeculoplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223132 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223132: Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223132
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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