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510(k) Data Aggregation
K Number
K102359Device Name
PICASSO/ PICASSO LITE/ PICASSO PERIO
Manufacturer
AMD LASERS, LLC
Date Cleared
2011-09-16
(393 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMD LASERS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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).
Device Description
Not Found
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K Number
K083142Device Name
PICASSO LASER SYSTEM
Manufacturer
AMD LASERS, LLC
Date Cleared
2009-03-13
(141 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AMD LASERS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The Picasso" is a diode laser with an 810 nm wavelength.
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