Beaver-Visitec International, Inc. · Class II · Cleared Apr 3, 2025
| K-number | K240615 |
| Device name | Leos Laser and Endoscopy System |
| Applicant | Beaver-Visitec International, Inc. |
| Product code | HQF |
| Device class | Class II |
| Decision date | Apr 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 886.4390 |
The Leos Laser and Endoscopy System is an 810 nm diode laser endoscopy device used for intraoperative photocoagulation of ciliary processes to treat glaucoma, proliferative retinopathies, and retinal detachment. It enables direct visualization and laser energy delivery to intraocular tissues through a sterilizable stainless-steel endoscopic probe (VueProbe) connected to a portable console with integrated monitors and wireless footswitch control.
The Leos System uses the same 810 nm treatment laser wavelength and 640 nm aiming laser as predicates, with identical power settings (50 mW increments, 0.05–1.2 W range) and duration modes. Key differences include: CMOS digital camera at the probe tip (vs. analog CCD in console), LED illumination in the probe (vs. xenon lamp from console), improved image resolution (40,000 vs. 10,000 pixels), lower aiming beam power (60 µW vs. 1500 µW), wireless footswitch with rotation control, single-use sterile probes (vs. reusable), and 19G probe options including curved (vs. 20G straight only).
IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60825-1 and IEC 60601-2-22 (laser safety), ANSI Z80.36 (optical safety), ISO 10993 (biocompatibility), ISO 11135 and ISO 11607-1 (sterilization), ASTM D4169-22 (packaging/transport), and IEC 62304 (software validation).
The Leos System delivers identical clinical therapy using the same treatment and aiming laser wavelengths, power ranges, and modalities as the predicates (Uram Endoscope K910532 and E2 Microprobe K042918). Differences in endoscopy technology (CMOS vs. CCD location, LED vs. xenon illumination) and form factors (probe design, console configuration, wireless footswitch) represent engineering improvements that do not alter the fundamental mechanism of action, indications, or safety profile. The device maintains equivalent or superior performance (e.g., 4× higher image resolution, lower aiming beam power requirement) without introducing new risks, and all changes support simplified sterilization (single-use probes) or enhanced usability rather than functional alterations.
View the full FDA submission: accessdata.fda.gov