Surgical Microscope (OMS2360, OMS2380)
Zumax Medical Co., Ltd.The Surgical Microscope OMS2360 and OMS2380 with Fluorescence Mode is a dental device designed for use by qualified dental professionals in hospitals. It provides powerful illumination and magnification during surgical procedures and examinations and includes a fluorescence feature that helps detect dental caries by illuminating tooth surfaces with blue LED light at 405 nm wavelength.
Intended Use
The surgical microscope is intended for use by qualified dental professionals in hospital operating rooms and hospital clinical settings to provide illumination and magnification of the surgical area and for visualization in surgical procedures or examinations (except ophthalmic surgeries). The fluorescence mode is intended as an adjunctive aid to assist in the detection of dental caries.
Technology
The Fluorescence Mode uses an LED light source emitting blue light at 405 nm wavelength to illuminate tooth surfaces. It is an accessory to the OMS2360, OMS2380 surgical microscopes which provide magnification and illumination of the surgical area. The devices include a microscope main body and multiple articulated arms allowing for flexible positioning.
Performance
Non-clinical performance testing included light safety testing per IEC 62471:2006, electrical safety and EMC testing per IEC60601-1 and IEC60601-1-2, and performance testing for fluorescence mode per ISO 10936-1:2000. Concurrence evaluation with clinical images showed equivalent diagnostic capability compared to predicate device.
Predicate Devices
No predicate devices specified
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