Medicell Mycosis Laser (MCML24004)

The Medicell Mycosis Laser is a medical laser device used to treat nail fungus (onychomycosis) by producing two wavelengths of light (635nm and 405nm) to create a photochemical reaction. The compact, floor-mounted device features a touchscreen interface and LCD monitor to guide treatment of fungal nail infections caused by dermatophytes and Candida species.

The device uses dual diode lasers producing 405nm and 635nm wavelengths at approximately 23mW and 17mW output power respectively, with constant wave output delivered via electronically scanned line patterns. Operating times of 12, 15, or 20 minutes (±5%) are available, controlled via LCD touchscreen on a compact unit measuring 540mm(W) × 304mm(L) × 405mm(H) and weighing 7.8kg.

IEC 60601-1:2020 (electrical safety and essential performance), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 62471:2008 (photobiological safety), and IEC 60825-1:2014 (laser equipment classification and safety).

The Medicell Mycosis Laser is substantially equivalent to predicate device K221363 (AF Laser) because both share identical intended use, indications for use, laser type, wavelengths, output characteristics, and operating principles. Both are Class II devices under 21 CFR 878.4810 that function as diode lasers for temporary clearance of fungal nails, with comparable performance specifications and passing all required safety and performance testing.