510(k) · Cleared
Recalled · Class II · 2012Pascal Streamline Photocoagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optimedica Corporation · HQF Laser, Ophthalmic
Cleared on May 4, 2010 as substantially equivalent to K092621 (Topcon Medical Laser Systems, Inc., 2009) after a 119-day review. Its family tree reaches back 6 generations to 1989. 16 later devices descend from it. It has been recalled once.
- Decided
- May 4, 2010
- Review
- 119 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K894841 (1989). 23 ancestors in all, the oldest K812219 (1981). 16 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 5 generations backK960971 Oculight GLIriderm Div. · 1996
- 4 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 3 generations backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- 2 generations backK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- 1 generation backK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- This deviceK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010
- 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 · 3 generations on · 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
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 · 3 generations on2descendants
- 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 |
|---|---|---|---|---|---|
| −6 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −5 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −4 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −3 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| −2 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| −1 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| 0 (this device) | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | — |
| +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 |
| +3 | 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 | — |
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 |
|---|---|---|
| 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 |
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 |
|---|---|---|---|
| * | K092621 | Pascal Streamline PhotocoagulatorSummary page 1…: PASCAL® Streamline'Tm Photocoagulator Generic/Common Name: Laser instrument, surgical, powered Laser, ophthalmic Predicate Device: PASCAL Streamline Photocoagulator (K092621) OPTIMEDICA CORPORATION PASCAL® STREAMLINE TM PHOTOCOAGULATOR SECTION 6 5… | 2009 |
What descends from it? (16)
See all 163 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 |
|---|---|---|---|---|
| Mar 27, 2012 | Class II | Z-1774-2013 | Software design | When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K111108 (Topcon Medical Laser Systems, Inc., 2011) has gone furthest, with 15 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. 2010, 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 Streamline Photocoagulator indications for use are the following:
Intended for use in the treatment of ocular pathology in the posterior segment. 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
Intended for use in the treatment of ocular pathology in the anterior segment including:
* iridotomy
* trabeculoplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100019: Pascal Streamline Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100019
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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