510(k) · Cleared
Recalled · Class II · 2025Leos Laser and Endoscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beaver-Visitec International, Inc. · HQF Laser, Ophthalmic
Cleared on Apr 3, 2025 as substantially equivalent to K910532 (Martin S. Knopf Assoc., Inc., 1991) and 1 other predicate after a 394-day review. Its family tree reaches back 1 generation to 1991. It has been recalled once.
- Decided
- Apr 3, 2025
- Review
- 394 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910532 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK910532 Uram Ophthalmic Laser EndoscopeMartin S. Knopf Assoc., Inc. · 1991
- This deviceK240615 Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910532 | Uram Ophthalmic Laser Endoscope | Martin S. Knopf Assoc., Inc. | 1991 | — |
| 0 (this device) | K240615 | Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K910532 | Uram Ophthalmic Laser EndoscopeSummary page 5…Device Common Name Ophthalmic Laser and Endoscopy System Trade/Proprietary Name Uram Ophthalmic Laser Endoscope 510(k) Number K910532 Device Class Class 2 Regulation Number 886.4390 – Ophthalmic laser Product Code… | 1991 |
| * | K042918 | Microprobe Laser and Endoscopy System, Model E2Summary page 5…mmon Name Ophthalmic Laser and Endoscopy System Trade/Proprietary Name E2 Microprobe Laser and Endoscopy System 510(k) Number K042918 Device Class Class 2 Regulation Number 878.4810 – Laser surgical instrument for use in gener… | 2004 |
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 |
|---|---|---|---|---|
| Dec 5, 2025 | Class II | Z-1008-2026 | Process control | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Leos system is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view. Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic…
Read the full statement (145 words)
The Leos system is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view.
Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures.
Vitreoretinal Surgery - The endoscopically controlled endophotocoagulation that is possible with the ophthalmic laser endoscope is also useful for endophotocoagulation:
- During vitreous surgery to produce chorioretinal scar around retinal breaks or retinotomy sites.
- To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies.
- To perform intraoperative retinal photocoagulation on a scleral buckle.
- To perform intraoperative photocoagulation around focal neovascularization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240615: Leos Laser and Endoscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240615
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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