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The Picasso ™/Picasso Lite™/ Picasso Perio™ is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:

• Gingival troughing for crown impression .
• 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 (curettage, removal of diseased, inflamed and . necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility).
• Removal of highly inflamed edematous tissue affected by bacteria penetration of . the pocket lining and junctional epithelium.

Teeth Whitening Indications (Picasso Only):

• Laser assisted whitening/bleaching of teeth .
• Light activation for bleaching materials for teeth whitening. .

New Indication for Use:

Laser periodontal:

Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).

Not Found

This document is a 510(k) premarket notification from the FDA for the AMD Lasers Picasso™/Picasso Lite™/Picasso Perio™ device. It primarily concerns the approval of new indications for use for an existing device and does not contain information about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. This document is a regulatory approval letter, not a study report.

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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.

Ask a specific question about this device