BTL-754FF

The BTL-754FF is a laser surgical system with two wavelengths (1540nm and 2940nm) used for dermatological and surgical procedures including skin resurfacing, ablation, coagulation, and treatment of wrinkles, acne scars, pigmented lesions, and vascular lesions. It consists of a main console unit with a touch screen, articulated mirror arm, and interchangeable handpieces (BTL-754-1 and BTL-754-4) that deliver laser energy to tissue.

The BTL-754FF uses Er:YAG (2940nm) and Er:Glass (1540nm) solid-state laser sources in pulsed mode with adjustable parameters. The 2940nm handpiece operates at 1.5-30 Hz repetition rate with pulse widths of 0.2-1.5 ms and microbeam sizes of 200 μm, while the 1540nm operates at 1-4 Hz with 2-8 ms pulses and 250 μm microbeams. Minor differences from the predicate BTL-754 include tighter microbeam tolerances (±30% vs ±20%) and slightly adjusted repetition rates and fluence ranges.

The device complies with IEC 60601-1:2020, IEC 60601-1-2:2020, IEC 60601-2-22:2019, IEC 60825-1:2014, ISO 10993 biocompatibility standards (parts 5, 10, 11, 23), and sterilization standards ISO 11737-1:2018+A1:2021, ISO 11737-2:2019, ISO 17664-1:2021, and ISO 17665:2024. Software documentation was provided per FDA guidance on device software functions.

The BTL-754FF has the same intended use and comparable technological characteristics as multiple predicate devices (BTL-754, Alma Harmony, Superbium, Aramis II, and Dermablate), all laser surgical instruments for dermatological and surgical applications. The differences in operational parameters and minor design variations have no significant influence on safety and effectiveness, making the device substantially equivalent to its predicates.