Diode laser device (BM091)

The BM091 is a diode laser device intended for hair removal and permanent hair reduction across all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in hair regrowth measured at 6, 9, and 12 months after completing a treatment regime.

The device uses a single-band 808 nm semiconductor diode laser with a 12mm × 20mm spot size, fluence range of 2–60 J/cm², frequency of 1–10 Hz, and pulse duration of 5–200 ms. It has dimensions of 375mm × 440mm × 1170mm and weighs 63 kg, powered by AC 100–240V/50–60Hz.

IEC 60601-1 Edition 3.2 (general medical electrical equipment safety), IEC 60825-1:2014 (laser safety), IEC 60601-2-22:2012 (surgical laser equipment), ISO 10993-5, ISO 10993-10, and ISO 10993-23 (biocompatibility), and IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility).

The proposed device has identical classification, product code, intended use, laser type, wavelength, and operational parameters (frequency, pulse duration, power supply) as the predicate K232709. Differences in spot size, fluence, and physical dimensions do not affect safety or effectiveness: spot size only changes treatment area; fluence is verified safe and effectiveness is supported by the reference device K241642 with similar fluence; and dimensions/weight affect only physical specification with no impact on performance. All non-clinical testing confirms compliance with applicable standards.