Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Picasso Pro Diode Laser is indicated for dentistry and oral soft tissue procedures of: 1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulp extirpation, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue. 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions; 3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
The Picasso Pro Diode Laser is indicated for dentistry and oral soft tissue procedures of: 1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulp extirpation, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue. 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions; 3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
The Picasso Pro Diode Laser is a powered laser surgical instrument classified under product codes GEX, NVK, EEG. It is designed for use in dental and oral soft tissue procedures.
Summary parsed at:2026-06-01 05:19:03 UTC
