Diode laser therapy device (VADER)

The VADER is a diode laser therapy device intended for hair removal and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. It uses an 808nm wavelength semiconductor diode laser that targets melanin in hair follicles, destroying germinal cells while sparing surrounding tissue. Permanent hair reduction is defined as long-term, stable reduction in hair regrowth measured at 6, 9, and 12 months after treatment completion.

The VADER operates at 808nm wavelength with a 12×12mm spot size, fluence range of 1–125 J/cm², frequency of 1–10 Hz, and pulse duration of 10–400ms. It has a smaller footprint (436×318×271mm, 24kg) compared to the predicate K210168 (450×430×1000mm, 52kg) and operates on AC 110V/60Hz power. The device includes a main unit, handpiece with removable treatment heads, and foot control activation.

The device was tested against IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (laser equipment safety), IEC 60825-1 (laser product safety), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation). No clinical studies were included in the submission.

The VADER is substantially equivalent because it uses the same diode laser technology at the same 808nm wavelength as predicate K210168, targets the same indication (hair removal with permanent hair reduction), operates within overlapping ranges for key parameters (fluence 1–125 J/cm² versus predicate 1–75 J/cm²), and meets identical electrical safety and EMC standards. Minor differences in spot size, dimensions, weight, and fluence range do not affect safety or effectiveness because spot size only changes treatment area, physical differences raise no mechanical performance issues under IEC 60601-1 compliance, and fluence remains within the safe and effective range demonstrated by predicate and reference devices. Biocompatibility testing confirms no cytotoxicity, sensitization, or irritation, matching the predicate device profile.