Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)

The Medical Diode Laser Hair Removal Device (five models: PZ-606VI, PZ-BDT68-01 through PZ-BDT68-04) is intended for permanent hair reduction on all skin types (Fitzpatrick I-VI) using an 808 nm diode laser. Permanent hair reduction is defined as long-term, stable reduction in regrowing hairs measured at 6, 9, and 12 months after completing a treatment regime. The device employs selective light absorption by melanin in hair follicles combined with cooling technology to protect skin.

All five models use an 808 nm diode laser with the same mechanism of action as the predicate but differ in minimum energy density and pulse duration parameters. The proposed device offers three spot sizes (0.28, 1.44, and 2.88 cm²) versus the predicate's single 1.44 cm² spot. Energy density ranges vary by model (2–95 J/cm²), pulse durations range from 3–108 ms, and the device features handle-button activation versus the predicate's foot control.

IEC 60601-1:2005+A1:2012+A2:2020 (electrical safety), IEC 60601-1-2:2014+A1:2020 (EMC), IEC 60601-2-22:2019 (surgical laser equipment), IEC 60825-1:2014 (laser product safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (irritation testing).

The proposed device shares the same 808 nm wavelength, diode laser type, intended use, indication, and mechanism as the predicate (K161692). Though differences exist in spot sizes, energy density ranges, pulse duration, power supply, and dimensions, the applicant argues these do not raise new safety issues because: (1) additional spot sizes align with sizes found in other cleared devices (K140009, K210663); (2) pulse duration overlaps with reference device K141973 (2.9–348 ms); (3) energy density remains within predicate ranges; and (4) all variants passed identical electrical safety, EMC, and laser safety standards per IEC requirements.