510(k) · Cleared
ClearedLaserex LP1532 Photocoagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellex Medical Pty, Ltd. · HQF Laser, Ophthalmic
Cleared on Oct 3, 1997 after an 88-day review. The FDA summary names its predicate without a number. 30 later devices descend from it.
- Decided
- Oct 3, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 1 citing it directly.
- This deviceK972514 Laserex LP1532 PhotocoagulatorEllex Medical Pty, Ltd. · 1997
- Descendant · cites it directly · 29 of its ownK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- Descendant · 2 generations on · 23 of its ownK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- Descendant · 3 generations on · 22 of its ownK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- Descendant · 2 generations on · 17 of its ownK081744 Pascal Synthesis Delivery SystemOptimedica Corporation · 2008
- Descendant · 4 generations on · 16 of its ownK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005 · cites it directly29descendants
- K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009 · 2 generations on23descendants
- K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009 · 3 generations on22descendants
- K081744Pascal Synthesis Delivery SystemOptimedica Corporation · 2008 · 2 generations on17descendants
- K100019Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972514 | Laserex LP1532 Photocoagulator | Ellex Medical Pty, Ltd. | 1997 | — |
| +1 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| +2 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| +3 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| +2 | K081744 | Pascal Synthesis Delivery System | Optimedica Corporation | 2008 | — |
| +4 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 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? (4)
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 |
|---|---|---|---|
| * | — | Alcon Ophthalas 532 Named without a submission number | |
| * | — | Alcon Eyelite Named without a submission number | |
| * | — | Iris Occulite Named without a submission number | |
| * | — | Nidek Prima Named without a submission number |
What descends from it? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043486 | Pascal Photocoagulator, Product-Pascal-01 | 2005 | 29 |
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?
- Of its descendants, K043486 (Topcon Medical Laser Systems, Inc., 2005) has gone furthest, with 29 descendants of its own.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 indication for use for this product are; » Retinal Photocoagulation « Photocoagulation for Macular Degeneration « Pan Retinal Photocoagulation ¢ Laser Trabeculoplasty « Endophotocoagulation. A General Description of these Treatments are; The indications for use for this product are: Retinal treatments, including; . Retinal Photocoagulation . Pan Retinal Photocoagulation . Endophotocoagulation These treatments involve the destruction of neovascular…
Read the full statement (207 words)
The indication for use for this product are;
» Retinal Photocoagulation « Photocoagulation for Macular Degeneration
« Pan Retinal Photocoagulation ¢ Laser Trabeculoplasty
« Endophotocoagulation.
A General Description of these Treatments are;
The indications for use for this product are:
Retinal treatments, including;
. Retinal Photocoagulation
. Pan Retinal Photocoagulation
. Endophotocoagulation
These treatments involve the destruction of neovascular complexes, to obliterate areas of microinfarction or
capillary closure.
Retinal Photocoagulation will be carried out using principally the Slittamp Delivery System accessory.
Pan Retinal Photocoagulation will be carried out using either of the Laser Indirect Ophthalmoscope or the
Slitlamp Delivery System accessory.
Endophotocoagulation will be carried out using any one of the three variants of the endoprobe accessories,
namely Straight, Curved or Aspirating Endooccular Probes.
Photocoagulation for Macular Degeneration involves the destruction of leaking vessels in the macular and
paramacular region, and ultimately to produce a chorioretinal adhesion that will resist ongoing vitreoretinal
traction. This treatment will be carried out using the slittamp microscope mounted Slitlamp Delivery System
accessory.
Laser Trabeculoplasty, the photocoagulation of the trabecular meshwork to create apertures and increase
the flow of the aqueous humor in order to treat open-angle-glaucoma. This treatment will be tarried out using
the slittamp microscope mounted Slittamp Delivery System accessory.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972514 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972514: Laserex LP1532 Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972514
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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