Diode Laser Therapy Systems (V19)

The Diode Laser Therapy Systems (V19) is a hair removal device intended for patients with hirsutism, indicated for all skin types (Fitzpatrick I-VI) including tanned skin. It uses selective photothermal dynamics at 808 nm wavelength to destroy hair follicles, with permanent hair reduction defined as long-term stable reduction measured at 6, 9, and 12 months post-treatment.

The device operates at 808 nm wavelength with a spot size of 12 mm × 24 mm (2.88 cm²), fluence of 100 J/cm², pulse duration of 1–200 ms, and frequency of 1–10 Hz. It comprises a main console unit, handheld applicator, and foot control. Key materials include aluminum alloy and sapphire for patient contact surfaces, with compliance to IEC 60601 electrical safety and IEC 60825-1 laser safety standards.

The device was tested to EN ISO 10993-5:2009 (cytotoxicity), EN ISO 10993-23:2021 (skin sensitization), EN ISO 10993-10:2023 (irritation), IEC 60601-1:2005+A1:2012 (electrical safety), IEC 60601-2-22:2019 (laser equipment safety), IEC 60825-1:2014 (laser product safety), and IEC 60601-1-2:2014+A1 (electromagnetic compatibility). Software validation was documented per FDA guidance on medical device software.