Nd: YAG Laser Therapy Systems

The Nd: YAG Laser Therapy Systems is a laser surgical instrument intended for dermatological and general surgical use, including tattoo removal, treatment of benign vascular and pigmented lesions, hair removal, and skin resurfacing. It operates at two wavelengths (532nm and 1064nm) to target different ink colors and skin conditions.

The proposed device uses Nd: YAG laser technology with dual wavelengths (1064nm and 532nm), similar output energy and fluence to predicate devices, adjustable spot sizes (2-10mm), and frequency of 1-10Hz. Minor differences exist in pulse duration (5-10ns vs. 4-6ns predicate) and aiming beam wavelength (650nm vs. 635nm predicate), but these do not affect safety or effectiveness.

The device complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1 (laser safety), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation testing). Electrical safety and electromagnetic compatibility standards are also cited.

The proposed device is substantially equivalent to the predicate (K202758) because both are Nd: YAG laser systems with identical classification, indications for use, and regulatory pathway. Non-clinical testing demonstrates equivalent performance in output energy, fluence, and safety parameters. Minor differences in pulse duration and aiming beam wavelength do not affect clinical safety or effectiveness, as confirmed by passing all relevant IEC standards.