Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)

The Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) is a solid-state laser device intended for surgical and aesthetic applications in dermatology, general surgery, and plastic surgery. It delivers energy at 1064 nm wavelength for dark tattoo ink removal on all skin types and 532 nm wavelength for lighter colored tattoo inks on lighter skin types (Fitzpatrick I-III), operating via a main unit, light guide arm, handpiece, and footswitch with LCD touchpad control.

The proposed device has identical wavelengths (1064 nm, 532 nm), pulse energy (500 mJ at 1064 nm, 250 mJ at 532 nm), spot size (2-10 mm), and handpiece design compared to the predicate. It differs minimally in pulse width (350 ps versus 300-400 ps) and laser delivery type (light guide arm versus articulated arm), both deemed non-significant because the device passed equivalent safety and performance testing standards.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-2-22 (laser equipment safety), and IEC 60825-1 (laser product safety and classification).

The proposed device is substantially equivalent to the predicate PICOCAREMAJESTY (K212127) because both share identical indications for use, anatomical sites, regulatory classification (Class II, 21 CFR 878.4810), product codes (GEX), principles of operation, and key performance parameters. Minor differences in pulse width and delivery system design do not affect safety or effectiveness, as the proposed device complies with all applicable safety and performance standards equivalent to the predicate.