Medical Diode Laser Hair Removal System (MNLT-D1)

The Medical Diode Laser Hair Removal System (MNLT-D1) is a Class II medical device that uses an 808nm semiconductor diode laser to remove hair and achieve permanent hair reduction across all skin types (Fitzpatrick I-VI), including tanned skin. It operates on the principle of selective photothermolysis, where laser energy is absorbed by melanin in hair follicles, converting optical energy to heat to restrain hair follicle tissues.

The proposed device uses an 808nm diode laser with a spot size of 12mm × 21mm, fluence range of 1–65 J/cm², frequency of 1–10 Hz, and pulse duration of 10–320ms. Minor differences from the predicate include slightly different spot size (vs. 12.6mm × 20.6mm), fluence range (vs. 1–70 J/cm²), pulse duration lower bound (vs. 3–320ms), and different power supply/dimensions/weight specifications, none of which affect therapeutic function.

The device was tested to IEC 60601-1:2020 (medical electrical equipment general safety), IEC 60601-1-2:2020 (EMC), IEC 60601-2-22:2012 (laser equipment), IEC 60825-1:2007 (laser safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (irritation). No clinical study was conducted.

The proposed device is substantially equivalent because it shares the same product code (GEX), regulatory classification (Class II, 21 CFR 878.4810), intended indications for use, configuration (main unit, handpiece, foot control), and principle of operation (808nm diode laser) as the predicate K221312. All measured differences (spot size, fluence, pulse duration, power supply, dimensions, weight, and updated testing standards) are either within the predicate's parameter ranges or are physical/administrative variations that do not raise new safety or effectiveness concerns, as demonstrated by nonclinical testing to FDA-recognized standards and biocompatibility testing showing no cytotoxicity, sensitization, or irritation.