510(k) · Cleared
ClearedPascal Streamline 577 (with Accessories)
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 Aug 11, 2011 as substantially equivalent to K100019 (Optimedica Corporation, 2010) and 2 other predicates after a 113-day review. Its family tree reaches back 7 generations to 1989. 15 later devices descend from it.
- Decided
- Aug 11, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K894841 (1989). 26 ancestors in all, the oldest K812219 (1981). 15 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 6 generations backK960971 Oculight GLIriderm Div. · 1996
- 5 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 4 generations backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- 3 generations backK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- 2 generations backK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- 1 generation backK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
- This deviceK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- Descendant · cites it directly · 5 of its ownK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK141851 Navilas Laser SystemOd-Os GmbH · 2015
- Descendant · 2 generations on · 1 of its ownK223132 Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and…Iridex Corporation · 2022
- Descendant · cites it directly · 1 of its ownK171488 PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc. · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K121475Txcell Scanning Laser Delivery SystemIridex Corp · 2012 · cites it directly6descendants
- K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · cites it directly5descendants
- K141851Navilas Laser SystemOd-Os GmbH · 2015 · 2 generations on2descendants
- K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation · 2022 · 2 generations on1descendant
- K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc. · 2017 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −6 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −5 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −4 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| −3 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| −2 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| −1 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
| 0 (this device) | K111108 | Pascal Streamline 577 (with Accessories) | Topcon Medical Laser Systems, Inc. | 2011 | — |
| +1 | K121475 | Txcell Scanning Laser Delivery System | Iridex Corp | 2012 | — |
| +1 | K123542 | Pascal Synthesis (532NM/577NM) Opthalmic Laser | Topcon Medical Laser Systems, Inc. | 2013 | 1 |
| +2 | K141851 | Navilas Laser System | Od-Os GmbH | 2015 | — |
| +2 | K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | 2022 | — |
| +1 | K171488 | PSLT for PASCAL Streamline | Topcon Medical Laser Systems, Inc. | 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 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K100019 | Pascal Streamline PhotocoagulatorSummary page 1…cate Devices * PASCAL Streamline Photocoagiilator, now owned/manufactured by Topcon Medical Laser Systems (TMLS; previously owned by OptiMedica) (K100019) * SUPRA 577.Y Photocoiagulator, manufactured by Quantel Medical (K091581) " IQ577 Photocoagulator, manufactu… | 2010 |
| * | K091581 | Supra 577.Y LaserSummary page 1…by Topcon Medical Laser Systems (TMLS; previously owned by OptiMedica) (K100019) * SUPRA 577.Y Photocoiagulator, manufactured by Quantel Medical (K091581) " IQ577 Photocoagulator, manufactured by IRIDEX Corp. (K07 1687) IV. Product Description The PASCAL®… | 2009 |
| * | K071687 | Famili of Iridex IQ Laser SystemsSummary page 1…ptiMedica) (K100019) * SUPRA 577.Y Photocoiagulator, manufactured by Quantel Medical (K091581) " IQ577 Photocoagulator, manufactured by IRIDEX Corp. (K07 1687) IV. Product Description The PASCAL® Streamline 577 (with Accessories) is an Optically Pumped Semicon… | 2008 |
What descends from it? (15)
See all 157 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121475 | Txcell Scanning Laser Delivery System | 2012 | 6 |
| K123542 | Pascal Synthesis (532NM/577NM) Opthalmic Laser | 2013 | 5 |
| K171488 | PSLT for PASCAL Streamline | 2017 | 1 |
| K142172 | Lightmed Truscan 577 | 2015 | 1 |
| K120825 | Supra Scan Delivery System | 2012 | 1 |
| K130195 | Scanning Laserlink | 2013 | 0 |
| K123056 | Pascal Laser Indirect Ophthalmoscope | 2012 | 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 22 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K121475 (Iridex Corp, 2012) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K100019.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
PASCAL® Streamline 577 (with Accessories) is 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: a proliferative and nonproliferative diabetic retinopathy *macular edema *choroidal neovascularization *branch and central retinal vein occlusion *…
Read the full statement (94 words)
PASCAL® Streamline 577 (with Accessories) is 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:
a proliferative and nonproliferative diabetic retinopathy
*macular edema
*choroidal neovascularization
*branch and central retinal vein occlusion
* the treatment of choroidal neovascularization associated with wet age-related macular degeneration
*lattice degeneration
*retinal tears and detachments
*retinopathy of prematurity
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/K111108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111108: Pascal Streamline 577 (with Accessories).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111108
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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