Nd: YAG Laser Therapy System (QN-1)

The Nd:YAG Laser Therapy System (QN-1) is a Class II laser surgical instrument that delivers therapeutic laser energy at wavelengths of 1064nm or 532nm in single-pulse mode. It is indicated for treating benign skin lesions including warts, scars, striae, psoriasis, pigmented lesions (lentigines, nevi, birthmarks), and removal of black or blue tattoos through rapid thermal ablation of target tissue.

The device operates at identical wavelengths (1064nm and 532nm) with comparable output energy ranges and maximum energy density to the predicate device. Key specifications match: 6-nanosecond pulse width, 2-10mm spot size, Class 4 laser classification, and closed-water circulation cooling. The primary difference is a more intense red aiming beam (10mW at 650nm versus <6mW in the predicate), which the applicant argues provides better user feedback without affecting safety or effectiveness.

IEC 60601-1:2020 (general medical electrical equipment safety), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-2-22:2019 (surgical laser equipment), IEC 60825-1:2007 (laser safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (irritation), and IEC TR 60601-4-2:2016 (EMC guidance).

The proposed device is substantially equivalent because it shares the same product code (GEX), regulatory classification (Class II under 21 CFR 878.4810), intended use, laser medium (Nd:YAG), wavelengths, energy output ranges within allowable tolerances, spot size, pulse width, and safety compliance standards as the predicate. Minor differences—slightly higher output energy specifications and a brighter aiming beam—are within acceptable tolerances and do not introduce new safety concerns based on bench testing that mirrors predicate device testing methodologies.