510(k) · Cleared
Recalled · Class II · 2023Integre Pro, Model L2RY
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 Jul 2, 2008 as substantially equivalent to K052777 (Ellex Medical Pty, Ltd., 2006) after a 28-day review. Its family tree reaches back 1 generation to 2006. It has been recalled once.
- Decided
- Jul 2, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052777 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK052777 Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including…Ellex Medical Pty, Ltd. · 2006 · Recalled
- This deviceK081565 Integre Pro, Model L2RYEllex Medical Pty, Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052777 | Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models… | Ellex Medical Pty, Ltd. | 2006 | 2 |
| 0 (this device) | K081565 | Integre Pro, Model L2RY | Ellex Medical Pty, Ltd. | 2008 | — |
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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2023 | Class II | Z-1971-2023 | Radiation Control for Health and Safety Act | When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K052777.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Integre family of Ophthalmic laser and Delivery Devices are intended to be used in the treatment of ocular pathology. The Ellex Integre Pro L2RY is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: * Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy; -…
Read the full statement (100 words)
The Integre family of Ophthalmic laser and Delivery Devices are intended to be used in the treatment of ocular pathology.
The Ellex Integre Pro L2RY is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
* Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy;
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-related macular degeneration;
- retinal tears and detachments;
- retinopathy of prematurity;
* Iridotomy, iridectomy, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081565: Integre Pro, Model L2RY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081565
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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