# K042918: Microprobe Laser and Endoscopy System, Model E2

- Pathway: 510(k) (Special)
- Applicant: Endooptiks, Inc.
- Decided: Nov 22, 2004 after 31 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Uram Ophthalmic Laser Endoscope - MicroProbe: named in the summary without a submission number

## Most influential descendants
- K240615: Leos Laser and Endoscopy System (2025), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K042918
Methodology: https://510kreport.com/methodology