510(k) · Cleared
ClearedPascal Laser Indirect Ophthalmoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Medical Laser Systems, Inc. (Tmls) · HQF Laser, Ophthalmic
Cleared on Nov 13, 2012 as substantially equivalent to K062336 (Optimedica Corporation, 2006) and 1 other predicate after a 43-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Nov 13, 2012
- Review
- 43 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K894841 (1989). 50 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- Root · 8 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 7 generations backK960971 Oculight GLIriderm Div. · 1996
- 6 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 5 generations backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- 4 generations backK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- 3 generations backK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- 2 generations backK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
- 1 generation backK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- This deviceK123056 Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −7 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −6 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −5 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| −4 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| −3 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| −2 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
| −1 | K111108 | Pascal Streamline 577 (with Accessories) | Topcon Medical Laser Systems, Inc. | 2011 | — |
| 0 (this device) | K123056 | Pascal Laser Indirect Ophthalmoscope | Topcon Medical Laser Systems, Inc. (Tmls) | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K062336 | Optimedica Laser Indirect OphthalmoscopeSummary page 1…in General and Plastic Surgery and Dermatology 111. Predicate Devices " Optimedica Laser Indirect Ophthalmoscope (K062336) " Topcon Laser Indirect Ophthalmoscope (K1111O8) IV. Product Description The PASCAL Laser Indirect Oph… | 2006 |
| * | K111108 | Pascal Streamline 577 (with Accessories)Summary page 2…Ophthalmoscope are substantially equivalent to those of the predicate devices. K062336 K111108 The PASCAL® Laser Indirect Topcon LIO LIO Ophthalmoscope Topcon (form… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 50 ancestors have a recall of any class.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used 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: 532nm macular edema age-related macular…
Read the full statement (115 words)
The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used 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:
532nm
macular edema
age-related macular degeneration
lattice degeneration
retinal tears and detachments
577nm
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
retinopathy of prematurity
Intended for use in the treatment of ocular pathology in the anterior segment including:
577nm
iridotomy
trabeculoplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123056: Pascal Laser Indirect Ophthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123056
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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