Diode laser device (RF3120-BI)

The Diode Laser Device (RF3120-BI) is a dermatological laser system with multiple handpieces for hair removal and vascular lesion treatment. It operates in three modes: Trio-Wavelength FHR mode for temporary hair reduction, HR mode for benign vascular lesions, and an 810nm handpiece for permanent hair reduction across all skin types (Fitzpatrick I-VI).

The device uses semiconductor laser technology with an 808nm single-band handpiece and a tri-wavelength (755nm/808nm/1064nm) handpiece. Minor differences from predicates include spot size variations (1-4 cm² for trio-wavelength vs. 2-4 cm² predicate), energy fluence ranges (2-60J/cm² for trio vs. 2-120J/cm² predicate), and pulse frequency adjustability (1-10Hz vs. 0.5-3Hz predicate), all within safe operating parameters.

IEC 60601-1 Edition 3.2 (general electrical safety), IEC 60825-1:2014 (laser safety), IEC 60601-2-22:2012 (particular requirements for surgical lasers), ISO 10993-1 and ISO 10993-23 (biocompatibility testing), and IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility).

The proposed device shares identical laser classification, module power, wavelengths, pulse width, and cooling method with predicates. Although spot size and energy fluence parameters differ, these variations do not impact safety or effectiveness because thermal effects depend on energy per unit area, and the device's parameters remain within established safe ranges. The proposed device passed the same international standards (IEC 60601-1, IEC 60825-1, IEC 60601-2-22) as predicates, demonstrating equivalent performance and safety profiles.