Surgical Microscope (OMS2360, OMS2380)

The Zumax Medical surgical microscope (OMS2360, OMS2380) is a dental surgical microscope that provides illumination and magnification for dental procedures and examinations. It includes a fluorescence mode with 405nm blue LED light that enables detection of dental caries as an adjunctive aid in hospital clinical settings.

The subject device features a 405nm LED fluorescence mode for caries detection, light intensity of ≥90,000 lx at 200mm working distance, working distance of 200-450mm, 40VA power source, and mechanical controls for light source and filter. The predicate device has similar specifications with 97,540 lx intensity at 200mm, 200-430mm working distance, and 120VA power.

ISO 10936-1:2000 (Optical microscopes requirements and test methods), IEC 60601-2:2014 and IEC 60601-1:2005 (electrical safety), IEC 62471:2006 (photobiological safety of lamps), IEC 62366-1:2015 (usability), IEC 60601-1-6:2020, and IEC80601-2-60:2019.

The subject device is substantially equivalent to predicate device K171007 because both use identical 405nm fluorescence technology for caries detection, share the same regulatory classification (Class II, NBL product code), meet the same safety and performance standards, and demonstrate equivalent diagnostic capability. Minor differences in light intensity, working distance, power, and software controls do not affect safety or effectiveness.