Picasso Pro Diode Laser (002-00460)

The Picasso Pro Diode Laser is a dental surgical instrument that delivers laser energy at 810±20nm wavelength to oral and soft tissue for procedures including lesion removal, hemostasis, and teeth whitening. It is used by licensed dental professionals in the dental operatory and features adjustable power output (0.5–7.0 watts), continuous or pulsed delivery, and a 630nm aiming beam.

The device generates laser energy via solid-state diodes at 810±10nm with maximum 7 watts output, compared to the predicate Precise SHP which outputs 0.5–3.0 watts at the same wavelength. Both feature identical handpiece design (anodized aluminum), single-use fiber tips (polypropylene housing with Type 316 stainless steel canula), wireless foot-switch activation, and 650±20nm aiming beam. The submitted device has larger physical dimensions (10" × 7.5" × 5.5") and an enhanced user interface compared to the predicate.

The device was validated against IEC 60601-1 Edition 3.2 (general safety), IEC 60601-1-6 Edition 3.2 (usability), IEC 60601-2-22 Edition 3.1 (laser equipment safety), IEC 60825-1 Edition 2.0 (laser product safety), and IEC 62366-1 Edition 1.1 (usability engineering). Software verification and validation testing followed FDA guidance on device software functions.

The submitted device is substantially equivalent because it is identical in materials and laser construction to the predicate Precise SHP Diode Laser, uses the same handpiece design and fiber tips as the reference Picasso Plus, operates at the same wavelength and principle, and shares identical indications for use with the predicate (with one additional indication—pulp extirpation—borrowed from the NeoLas 810 reference device). No new safety or effectiveness issues are raised.