INTEGRE LIO

The INTEGRE LIO is a laser photocoagulator using a 532 nm green diode laser mounted in a lightweight, battery-powered headset worn by the physician. It includes a wireless footswitch for controlling treatment parameters and is indicated for use in ophthalmic laser procedures including retinal photocoagulation.

The device uses a 532 nm diode laser (versus 520 nm in the predicate), both operating in continuous wave mode with identical maximum power output (1000 mW), pulse duration (10-1000 ms), spot size (1.1 mm), and beam divergence (31 mrad). Both devices employ a 635 nm red aiming laser diode and dimmable white LED illumination.

IEC 60601-1 and IEC 60601-1-2 (medical electrical equipment safety and EMC), IEC 60601-2-22 (laser equipment requirements), IEC 60825-1 (laser product safety), ISO 15004-2 (ophthalmic instruments light hazard protection), ANSI Z80.36-2021 (light hazard protection), plus FDA software verification/validation and human factors testing.

The INTEGRE LIO is substantially equivalent to the predicate Norlase LIO because both are Class II ophthalmic laser photocoagulators with identical intended use and indications for retinal photocoagulation. Both use diode laser technology with nearly identical specifications; the minor wavelength difference (532 nm vs 520 nm) is immaterial since both are green lasers with the same photocoagulation mechanism of action and both comply with applicable safety standards.