Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)

The Non-contact Forehead Infrared Thermometer (models FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) is a non-sterile, reusable, handheld device that measures human body temperature by detecting infrared heat from the forehead. It is intended for use by consumers in home care and by doctors in clinical settings for people over one month old.

The subject device has a measuring range of 32.0°C–42.9°C (89.6°F–109.2°F) with ±0.4°F/±0.2°C accuracy, measurement distance of 0-3cm, LCD digital display with 0.1°C/0.1°F resolution, memory for 35 sets, and operates on two AAA alkaline batteries. Compared to the predicate, the measurement distance differs (0-3cm vs. 3-5cm), memory capacity differs (35 vs. 32 sets), and the measuring accuracy specification is slightly tighter, though all meet ISO 80601-2-56 requirements.

IEC 60601-1:2020, IEC 60601-1-2:2020, ISO 80601-2-56:2017+A1:2018, IEC 60601-1-11:2020, ISO 10993-1, ASTM E1965-98 (Reapproved 2016), and FDA guidance on device software functions.

The subject device is substantially equivalent because it has the same intended use, regulatory classification (Class II), product code (FLL), and technological approach as the predicate (infrared forehead thermometry). Although there are minor differences in measurement distance, memory capacity, and accuracy specifications, the submitter demonstrated through testing that these differences do not raise new safety or effectiveness concerns, and all performance parameters comply with the same consensus standards (ISO 80601-2-56 and ASTM E1965-98) that the predicate met.