Infrared Thermometer

The Infrared Thermometer is a non-sterile, reusable, handheld device that measures human body temperature for all ages by detecting infrared heat from the forehead and/or auditory canal. It is non-contact for forehead measurements and intended for consumer use in homecare environments. Four models are offered with varying measurement distances and capabilities (T30, TE-82, TE-79, TE-102).

The subject device uses a thermopile sensor with 0.1°C/°F display resolution and 1-second response time. Key differences from the predicate include: LCD/LED display versus LCD-only; BLE 5.0 Bluetooth connectivity versus no wireless capability; measurement distance ranges of 1–3 cm (T30) or 3–5 cm (TE-102/TE-79) versus 1–5 cm; and use of ABS and PC materials versus ABS alone. Memory capacity is 32 or 24 sets versus 32 sets.

IEC 60601-1:2020, IEC 60601-1-11:2020, IEC 60601-1-2:2020, ISO 80601-2-56, ISO 10993-1 (biocompatibility), FCC CFR Title 47 Part 15 Subpart C (Bluetooth), and FDA software guidance documents. Performance testing included minimum 150 subjects across four age groups per ISO 80601-2-56.

The subject device is substantially equivalent because it shares the same intended use (body temperature measurement via infrared detection), measurement principle (thermopile sensor), target population (all ages), and operating environment (homecare) as the predicate. All differences (display type, Bluetooth 5.0 versus no wireless, material composition, measurement distance variants) do not raise new safety or effectiveness questions: the device complies with applicable performance standards, has demonstrated clinical accuracy per ISO 80601-2-56 in controlled testing, and the predicate's measurement range (1–5 cm) encompasses the subject's variants. Biocompatibility testing confirms material safety, and electromagnetic/electrical safety testing validates compliance with IEC standards applicable to both devices.