# K240615: Leos Laser and Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Beaver-Visitec International, Inc.
- Decided: Apr 3, 2025 after 394 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910532 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910532: Uram Ophthalmic Laser Endoscope, Martin S. Knopf Assoc., Inc. (1991) Summary page 5.
- K042918: Microprobe Laser and Endoscopy System, Model E2, Endooptiks, Inc. (2004) Summary page 5.

## Recalls of this device
- Dec 5, 2025 · Class II · Z-1008-2026: 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 fe

## Indications for use
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.

Source page: https://510kreport.com/device/K240615
Methodology: https://510kreport.com/methodology