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510(k) Data Aggregation

    K Number
    K240615
    Device Name
    Leos Laser and Endoscopy System
    Manufacturer
    Beaver-Visitec International, Inc.
    Date Cleared
    2025-04-03

    (394 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beaver-Visitec International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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
    Device Description
    The Leos Laser and Endoscopic System is a next generation ophthalmic laser and endoscopy system used for the treatment of glaucoma, vitreoretinal diseases, and intraocular visualization. The system contains an 810 nm powered diode laser delivered by the stainless-steel endoscopic laser probe (trade name: VueProbe), which is placed into eye tissue to illuminate and visualize the target tissue and deliver laser energy under direct visualization. The console is a fully integrated portable device, containing a laser module assembly, viewing and control monitors, and a wireless footswitch for activating the laser. The larger passive monitor is for viewing the endoscopic video image and key treatment information, while the smaller touchscreen is used for parameters selection, rotation and viewing. The camera chip uses CMOS technology and is located at the tip of the probe. The LED light source is located within the plastic handpiece of the probe and illumination fibers carry the light to the tip. Additionally, the probe contains a laser fiber within its full length.
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