510(k) · Cleared
ClearedLightmed Truscan 577
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightmed Corp. · HQF Laser, Ophthalmic
Cleared on Feb 27, 2015 as substantially equivalent to K111108 (Topcon Medical Laser Systems, Inc., 2011) after a 204-day review. Its family tree reaches back 8 generations to 1989. 1 later device descends from it.
- Decided
- Feb 27, 2015
- Review
- 204 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K894841 (1989). 27 ancestors in all, the oldest K812219 (1981). 1 later device descends from it, 1 citing it directly.
- 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 deviceK142172 Lightmed Truscan 577Lightmed Corp. · 2015
- Descendant · cites it directly · 0 of its ownK190448 LightLas Pattern Scanning System - TruScan ProLight-Med (Usa), Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190448LightLas Pattern Scanning System - TruScan ProLight-Med (Usa), Inc. · 2019 · cites it directly0descendants
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) | K142172 | Lightmed Truscan 577 | Lightmed Corp. | 2015 | — |
| +1 | K190448 | LightLas Pattern Scanning System - TruScan Pro | Light-Med (Usa), Inc. | 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 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K111108 | Pascal Streamline 577 (with Accessories)Summary page 4…Product code: HQF Performance Standards: 21 CFR 1040.10 & 21 CFR 1040.11 III. PREDICATE DEVICE PASCAL Streamline 577 (with Accessories), K111108 This predicate has not been subject to a design-related recall . IV. DEVICE DESCRIPTION LightMed TruS… | 2011 |
| † | K992836 | SL990, SL980, SL950 | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190448 | LightLas Pattern Scanning System - TruScan Pro | 2019 | 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 26 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K190448 (Light-Med (Usa), Inc., 2019) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K111108.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 LightMed TruScan 577 Laser System 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 structure abnormalities of the retina and choroid including:
1. Proliferative and Severe and very severe nonproliferative diabetic retinopathy
2. Clinically Significant Macular edema
3. Choroidal neovascularization
4. Branch and central retinal vein occlusion
5. The treatment of choroidal neovascularization associated with wet age-related macular degeneration
6. Lattice degeneration
7. Retinal tears and detachments
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142172: Lightmed Truscan 577.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142172
Report an extraction error
Are you the manufacturer?
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