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K Number
K102359
Device Name
PICASSO/ PICASSO LITE/ PICASSO PERIO
Manufacturer
AMD LASERS, LLC
Date Cleared
2011-09-16

(393 days)

Product Code
GEX
Regulation Number
878.4810
Type
Abbreviated
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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

AI/ML Overview

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.

§ 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.