510(k) · Cleared
ClearedPascal Photocoagulator, Product-Pascal-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Medical Laser Systems, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 3, 2005 as substantially equivalent to K022181 (Lumenis, Inc., 2002) and 4 other predicates after a 76-day review. Its family tree reaches back 3 generations to 1989. 29 later devices descend from it.
- Decided
- Mar 3, 2005
- Review
- 76 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K894841 (1989). 20 ancestors in all, the oldest K812219 (1981). 29 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 2 generations backK960971 Oculight GLIriderm Div. · 1996
- 1 generation backK020374 Oculight SL/SLXIridex Corp · 2002
- This deviceK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- Descendant · cites it directly · 23 of its ownK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- Descendant · 2 generations on · 22 of its ownK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- Descendant · cites it directly · 17 of its ownK081744 Pascal Synthesis Delivery SystemOptimedica Corporation · 2008
- Descendant · 3 generations on · 16 of its ownK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
- Descendant · 4 generations on · 15 of its ownK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009 · cites it directly23descendants
- K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009 · 2 generations on22descendants
- K081744Pascal Synthesis Delivery SystemOptimedica Corporation · 2008 · cites it directly17descendants
- K100019Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · 3 generations on16descendants
- K111108Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −2 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −1 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| 0 (this device) | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| +1 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| +2 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| +1 | K081744 | Pascal Synthesis Delivery System | Optimedica Corporation | 2008 | — |
| +3 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
| +4 | K111108 | Pascal Streamline 577 (with Accessories) | Topcon Medical Laser Systems, Inc. | 2011 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 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? (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 | Decided |
|---|---|---|---|
| * | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesSummary page 1…or devices to which substantial equivalence is being claimed: 510(k) Company Device Name K022181 Lumenis, Inc. Lumenis Novus Varia K972514 Laserex Systems… | 2002 |
| * | K972514 | Laserex LP1532 PhotocoagulatorSummary page 1…0(k) Company Device Name K022181 Lumenis, Inc. Lumenis Novus Varia K972514 Laserex Systems Laserex LP1 532 K020374 Iridex Corporation… | 1997 |
| * | K020374 | Oculight SL/SLXSummary page 1…K022181 Lumenis, Inc. Lumenis Novus Varia K972514 Laserex Systems Laserex LP1 532 K020374 Iridex Corporation Index Oculight SL/SLx K960971 Index Corporation… | 2002 |
| * | K960971 | Oculight GLSummary page 1…K972514 Laserex Systems Laserex LP1 532 K020374 Iridex Corporation Index Oculight SL/SLx K960971 Index Corporation Iridex Medical Oculight GL K971950 Infinitech, Inc.… | 1996 |
| * | K971950 | Infinitech Multi-Spot Slit Lamp Laser AdapterSummary page 1…Iridex Corporation Index Oculight SL/SLx K960971 Index Corporation Iridex Medical Oculight GL K971950 Infinitech, Inc. Infinitech Slit Lamp Laser Adapter OptiMedica TMCorporation… | 1997 |
What descends from it? (29)
See all 296 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 16 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K091666 (Optimedica Corporation, 2009) has gone furthest, with 23 descendants of its own.
- 13 other devices also cite its predicate K022181.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Photocoagulator indications for use are the following:
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Retinal photocoagulation, panretinal 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/K043486 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043486: Pascal Photocoagulator, Product-Pascal-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043486
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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