BTL-754

The BTL-754 is a laser surgical instrument with dual wavelengths (1540nm and 2940nm) designed for dermatological procedures. It performs coagulation, resurfacing, and ablation of soft tissue to treat wrinkles, scars, pigmented lesions, melasma, and other skin conditions. The device consists of a main console with touch screen controls, articulated mirror arm, and interchangeable handpieces.

The BTL-754 uses Er:YAG (2940nm) and Er:Glass (1540nm) laser sources in pulsed mode with similar microbeam sizes (250μm and 300μm respectively) and comparable fluence ranges to the predicate. Minor differences include pulse width ranges (0.2–1.5ms vs 0.25–5ms for 2940nm; 4–7ms vs 10–15ms for 1540nm) and repetition rates (1–3Hz vs up to 6Hz for 2940nm; 1–3Hz vs up to 1.5Hz for 1540nm), with slightly different application pattern densities.

IEC 60601-1:2020, IEC 60601-1-2:2020, IEC 60601-2-22:2019 for electrical safety and laser equipment; ISO 10993-5, 10993-10, 10993-11, 10993-23 for biocompatibility; ISO 11737-1, 11737-2, ISO 17664-1:2021, ISO 17665:2024 for sterilization validation.

The BTL-754 shares identical intended use (dermatological laser procedures for resurfacing, coagulation, ablation) and the same dual-wavelength laser technology as the predicate device. Both use fractional Er:YAG and Er:Glass handpieces with comparable wavelengths, microbeam sizes, and energy delivery mechanisms. The minor variations in pulse width, repetition rate, and application patterns are within clinically equivalent ranges and do not alter the fundamental safety or effectiveness profile, making functional equivalence established.