Diode laser hair removal machine (QDTM-02)

The QDTM-02 is a diode laser hair removal machine intended for permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term stable reduction in regrowing hairs measured at 6, 9, and 12 months after treatment completion.

Class IV diode laser operating at 808nm wavelength with frequency of 1-20Hz and pulse duration of 10-200ms. The device includes a main host unit with control panel, cooling system, and circuit controls, plus a treatment handpiece with interchangeable spot sizes (small: 1.44 cm² and large: 4 cm²). Dimensions match predicate devices; power supply specifications are similar.

IEC 60601-1:2005 (medical electrical device safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-2-22:2019 (surgical laser equipment), IEC 60825-1:2014 (laser product safety), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and hypersensitivity), and ISO 10993-23 (irritation testing).

The device shares identical product code (GEX), regulation number (21 CFR 878.4810), regulatory class (II), and indications for use with two predicate devices. All core parameters—laser type, wavelength, classification, and pulse characteristics—are identical or fall within predicate ranges. Minor differences such as larger handpiece spot size (4 cm² vs 2.4 cm²) are justified as similar to a legally marketed reference device and within safe, effective operating ranges. Biocompatibility testing confirms compliance with ISO 10993 standards despite material differences.