510(k) · Cleared
ClearedPascal Synthesis Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optimedica Corporation · GEX Powered Laser Surgical Instrument
Cleared on Sep 9, 2008 as substantially equivalent to K043486 (Topcon Medical Laser Systems, Inc., 2005) and 1 other predicate after an 82-day review. Its family tree reaches back 4 generations to 1989. 17 later devices descend from it.
- Decided
- Sep 9, 2008
- Review
- 82 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K894841 (1989). 21 ancestors in all, the oldest K812219 (1981). 17 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 3 generations backK960971 Oculight GLIriderm Div. · 1996
- 2 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 1 generation backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- This deviceK081744 Pascal Synthesis Delivery SystemOptimedica Corporation · 2008
- Descendant · cites it directly · 11 of its ownK100678 Supra Scan Delivery SystemQuantel Medical · 2010
- Descendant · 2 generations on · 6 of its ownK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- Descendant · 3 generations on · 5 of its ownK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
- Descendant · cites it directly · 4 of its ownK100035 Model Visulas 532S Laser with the Vite OptionCarl Zeiss Meditec, AG · 2010
- Descendant · 2 generations on · 2 of its ownK181682 VISULAS greenCarl Zeiss Meditec, AG · 2019
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K100678Supra Scan Delivery SystemQuantel Medical · 2010 · cites it directly11descendants
- K121475Txcell Scanning Laser Delivery SystemIridex Corp · 2012 · 2 generations on6descendants
- K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · 3 generations on5descendants
- K100035Model Visulas 532S Laser with the Vite OptionCarl Zeiss Meditec, AG · 2010 · cites it directly4descendants
- K181682VISULAS greenCarl Zeiss Meditec, AG · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −3 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −2 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −1 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| 0 (this device) | K081744 | Pascal Synthesis Delivery System | Optimedica Corporation | 2008 | — |
| +1 | K100678 | Supra Scan Delivery System | Quantel Medical | 2010 | — |
| +2 | K121475 | Txcell Scanning Laser Delivery System | Iridex Corp | 2012 | — |
| +3 | K123542 | Pascal Synthesis (532NM/577NM) Opthalmic Laser | Topcon Medical Laser Systems, Inc. | 2013 | 1 |
| +1 | K100035 | Model Visulas 532S Laser with the Vite Option | Carl Zeiss Meditec, AG | 2010 | — |
| +2 | K181682 | VISULAS green | Carl Zeiss Meditec, AG | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K043486 | Pascal Photocoagulator, Product-Pascal-01Summary page 1…ubstantially equivalent in intended use and has the same technological characteristics as the delivery system incorporated into PASCAL Photocoagulator (K043486). The PASCAL Synthesis Delivery System is also substantially equivalent to the Infinitech Multi-Spot Slit Lamp Laser Ada… | 2005 |
| * | K971950 | Infinitech Multi-Spot Slit Lamp Laser AdapterSummary page 1…PASCAL Photocoagulator (K043486). The PASCAL Synthesis Delivery System is also substantially equivalent to the Infinitech Multi-Spot Slit Lamp Laser Adapter (K971950) by Infinitech, Inc. in functionality and technology in that when this device is connected to another laser, it… | 1997 |
What descends from it? (17)
See all 174 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)
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 19 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K100678 (Quantel Medical, 2010) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K043486.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 PASCAL Synthesis Delivery System is a stand alone scanning delivery system that, when connected to compatible commercially available laser photocoagulators, allows fully functional scanning photocoagulation. When connected to a compatible laser system, the PASCAL Synthesis Delivery System is indicated for use in the treatment of ocular pathology in both the posterior and anterior segments, retinal photocoagulation, pan retinal photocoagulation, focal…
Read the full statement (119 words)
The PASCAL Synthesis Delivery System is a stand alone scanning delivery system that, when connected to compatible commercially available laser photocoagulators, allows fully functional scanning photocoagulation.
When connected to a compatible laser system, the PASCAL Synthesis Delivery System is indicated for use in the treatment of ocular pathology in both the posterior and anterior segments, retinal photocoagulation, pan retinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
* Proliferative and nonproliferative diabetic retinopathy
* Macular edema
* Choroidal neovascularization
* Branch and central retinal vein occlusion
* Age-related macular degeneration
* Lattice degeneration
* Retinal tears and detachments
* Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081744 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081744: Pascal Synthesis Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081744
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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