(141 days)
The Picasso" is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
· Gingival troughing for crown impressions
· Gingivectomy
· Gingivoplasty
· Gingival incision and excision
· Hemostasis and coagulation
· Excisional and incisional biopsies
· Exposure of unerupted teeth
· Fibroma removal
· Frenectomy and frenotomy
· Implant recovery
· Incision and drainage of abscess
· Leukoplakia
· Operculectomy
· Oral papillectomies
· Pulpotomy
· Pulpotomy as an adjunct to root canal therapy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Vestibuloplasty
Laser periodontal procedures, including:
· Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss and tooth mobility).
· Laser soft tissue curettage
· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket,
· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
Tooth Whitening Indications:
· Laser assisted whitening/bleaching of teeth.
· Light activation for bleaching materials for teeth whitening.
The Picasso" is a diode laser with an 810 nm wavelength.
The provided text is a 510(k) summary for the Picasso™ diode laser. It explicitly states under section 6, "Performance Data": "None presented."
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this data is not included in the provided document. The device was cleared based on substantial equivalence to predicate devices, rather than a new performance study demonstrating it meets specific acceptance criteria.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.