Medical Laser System Incanto / Evoline Platinum /Evoline

The Medical Laser System Incanto/Evoline Platinum/Evoline is a dual-wavelength laser system that combines 1064nm Nd:YAG and 755nm Alexandrite radiation for dermatological and surgical applications. It is indicated for hair reduction, treatment of pigmented and vascular lesions, wrinkle treatment, and temporary improvement of onychomycosis across all skin types (Fitzpatrick I-VI).

The proposed device features dual laser wavelengths (755nm Alexandrite and 1064nm Nd:YAG) with maximum fluence of 600 J/cm², frequency range of 0.5-10 Hz, pulse widths of 0.3-200 ms, and 13 selectable spot sizes (2-24 mm). It uses LCD touchscreen and footswitch controls with water and air cooling. The predicate K233090 has similar specifications, while K122493 (Nd:YAG only) operates at lower fluence (15-18 J/cm²) and limited spot size options.

IEC 60601-1:+A1:2012 (medical electrical equipment general safety), IEC 60601-1-2:2014+AMD1:2020 (electromagnetic compatibility), IEC 60825-1:2014 (laser product safety), IEC 60601-2-22:2019 (surgical laser equipment safety), and ISO 10993-1 (biocompatibility with cytotoxicity, sensitization, and irritation testing).

The proposed device shares the same indications for use, design features, technological characteristics, and operating principles as the predicate devices K233090 and K122493. Minor differences in spot size options and parameter ranges have been validated through non-clinical testing without raising new safety questions. The device demonstrates comparable safety and effectiveness through compliance with identical international standards for electrical safety, laser safety, and biocompatibility as its predicates.