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510(k) Data Aggregation
K Number
K152939Device Name
Picasso Plus, Picasso Lite Plus
Manufacturer
AMD GROUP LLC
Date Cleared
2015-11-25
(51 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMD GROUP LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Picasso Plus / Picasso Lite Plus 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; and Vestibuloplasty.
Laser Periodontal Procedures, including: Sulcular debridement (curettage, removal of diseased, infected, 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; and Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
Teeth Whitening Indications (Picasso Plus Only): Laser assisted whitening of teeth and Light activation for whitening materials for teeth whitening.
Device Description
The Picasso line of soft tissue dental lasers is designed for a wide variety of oral soft tissue surgical, non-surgical, and teeth whitening procedures. Picasso Plus and Picasso Lite Plus lasers employ semiconductor diodes as a laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The laser delivery used may be in the form of strippable fiber or a multi-tip handpiece that is used in conjunction with disposable tips. The device is activated by means of a wireless footswitch.
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