510(k) · Cleared
Recalled · Class II · 2016Pascal Synthesis (532NM/577NM) Opthalmic Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Medical Laser Systems, Inc. · HQF Laser, Ophthalmic
Cleared on May 15, 2013 as substantially equivalent to K092621 (Topcon Medical Laser Systems, Inc., 2009) and 2 other predicates after a 177-day review. Its family tree reaches back 9 generations to 1989. 5 later devices descend from it. It has been recalled once.
- Decided
- May 15, 2013
- Review
- 177 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 9 generations to K894841 (1989). 30 ancestors in all, the oldest K812219 (1981). 5 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 5 generations between
- 3 generations backK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
- 2 generations backK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- 1 generation backK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- This deviceK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK141851 Navilas Laser SystemOd-Os GmbH · 2015
- Descendant · cites it directly · 1 of its ownK223132 Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and…Iridex Corporation · 2022
- Descendant · 2 generations on · 1 of its ownK162191 NAVILAS Laser SystemOd-Os GmbH · 2016
- Descendant · 2 generations on · 0 of its ownK251772 Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
- Descendant · cites it directly · 0 of its ownK170409 PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemTopcon Medical Laser Systems, Inc. (Tmls) · 2017
Show all 9 generations
- Root · 9 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 8 generations backK960971 Oculight GLIriderm Div. · 1996
- 7 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 6 generations backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- 5 generations backK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- 4 generations backK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- 3 generations backK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
- 2 generations backK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- 1 generation backK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- This deviceK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- 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 · cites it directly1descendant
- K162191NAVILAS Laser SystemOd-Os GmbH · 2016 · 2 generations on1descendant
- K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025 · 2 generations on0descendants
- K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemTopcon Medical Laser Systems, Inc. (Tmls) · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −8 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −7 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −6 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| −5 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| −4 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| −3 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
| −2 | K111108 | Pascal Streamline 577 (with Accessories) | Topcon Medical Laser Systems, Inc. | 2011 | — |
| −1 | K121475 | Txcell Scanning Laser Delivery System | Iridex Corp | 2012 | — |
| 0 (this device) | K123542 | Pascal Synthesis (532NM/577NM) Opthalmic Laser | Topcon Medical Laser Systems, Inc. | 2013 | — |
| +1 | K141851 | Navilas Laser System | Od-Os GmbH | 2015 | — |
| +1 | K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | 2022 | — |
| +2 | K162191 | NAVILAS Laser System | Od-Os GmbH | 2016 | — |
| +2 | K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025 | — |
| +1 | K170409 | PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System | Topcon Medical Laser Systems, Inc. (Tmls) | 2017 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K092621 | Pascal Streamline PhotocoagulatorSummary page 1…Plastic Surgery and Dermatology; Laser, Powered Ill. Predicate Devices . Optimedica Ophthalmic Scanning Laser System (K092621) * Topeon Ophthalmic Scanning Laser System (KI 11108) * Iridex TxCell Adaptor/Photocoagulator System (K121475)… | 2009 |
| * | K111108 | Pascal Streamline 577 (with Accessories)Summary page 3…Synthesis Ophthalmic Scanning Laser System are substantially equivalent to those of the predicate. Technical K(092621 K(111108 K1214751K071687 K123542 Characteristics… | 2011 |
| * | K121475 | Txcell Scanning Laser Delivery System Cleared while this submission was under review Summary page 1…imedica Ophthalmic Scanning Laser System (K092621) * Topeon Ophthalmic Scanning Laser System (KI 11108) * Iridex TxCell Adaptor/Photocoagulator System (K121475) IV. Product Description The PASCAL® SvnthesisT,' Ophthalmic Scanning Laser System is a stand-alone laser de… | 2012 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2016 | Class II | Z-2405-2016 | Device Design | Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K141851 (Od-Os GmbH, 2015) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K092621.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The PASCAL® Synthesis Ophthalmic Scanning Laser System is 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: (532 nm) proliferative and non-proliferative diabetic retinopathy…
Read the full statement (124 words)
The PASCAL® Synthesis Ophthalmic Scanning Laser System is 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:
(532 nm)
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/K123542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123542: Pascal Synthesis (532NM/577NM) Opthalmic Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123542
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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