510(k) · Cleared
ClearedMicroprobe Laser and Endoscopy System, Model E2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endooptiks, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Nov 22, 2004 after a 31-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 22, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK042918 Microprobe Laser and Endoscopy System, Model E2Endooptiks, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK240615 Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 2025 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042918 | Microprobe Laser and Endoscopy System, Model E2 | Endooptiks, Inc. | 2004 | — |
| +1 | K240615 | Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | — | Uram Ophthalmic Laser Endoscope - MicroProbe Named without a submission number | |
| † | K910532 | Uram Ophthalmic Laser Endoscope | 1991 |
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 |
|---|---|---|---|
| K240615 | Leos Laser and Endoscopy System | 2025 | 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?
- Of its descendants, K240615 (Beaver-Visitec International, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The ophthalmic laser endoscope 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 allow a posterior view. Glaucoma This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and…
Read the full statement (169 words)
The ophthalmic laser endoscope 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 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.
The endophotocoagulation of ciliary processes under direct endoscopic view is highly controllable, i.e. titratable, and has been demonstrated to be effective in the treatment of glaucoma.
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/K042918 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042918: Microprobe Laser and Endoscopy System, Model E2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042918
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