(393 days)
Not Found
Not Found
No
The provided text describes a laser device for various oral soft tissue procedures and teeth whitening. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The description focuses solely on the device's intended uses and the procedures it can perform.
Yes
The device is used for various medical procedures such as incision, excision, and coagulation of oral soft tissues, as well as treatment of various oral conditions and laser periodontal procedures, which defines it as a therapeutic device.
No
The device's intended uses are for various surgical and therapeutic procedures on oral soft tissues and teeth, not for diagnosing conditions.
No
The intended use describes procedures performed with a laser device, which is a hardware component. The summary does not mention any software-only functionality.
Based on the provided information, the Picasso™/Picasso Lite™/ Picasso Perio™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses listed for this device involve direct interaction with and treatment of oral soft tissues and teeth within the patient's mouth.
- The listed procedures are surgical and therapeutic. They involve cutting, removing, and treating tissues and teeth directly, not analyzing samples taken from the body.
The device is a laser system used for various dental and periodontal procedures performed directly on the patient.
N/A
Intended Use / Indications for 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:
In addition to the aforementioned indications of use previously cleared by the FDA, the following indication is requested to be added:
Laser periodontal:
Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissues, gingival, periodontal pocket, teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring. MID 20993-0002
AMD Lasers, LLC % Ms. Amy Szentes 7405 Westfield Boulevard Indianapolis, Indiana 46240
SEP 1 6 2011
Re: K102359
Trade/Device Name: Picasso "/Picasso Lite""/Picasso Perio""" Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 06, 2011 Received: September 09, 2011
Dear Ms. Szentes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Ms. Amv Szentes
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRF's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
E. Keith
Cy Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for AMD Lasers. The logo consists of the text "AMD LASERS" in a stylized font. Below the logo is the text "Effective. Practical. Affordable. World Class Lasers".
Indications for Use
510(k) Number (if known): K102359
Device Name:
PICASSO™/ PICASSO LITE™/ PICASSO PERIO™
Indications For 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. .
Page 1 of 2
3
New Indication for Use:
In addition to the aforementioned indications of use previously cleared by the FDA, the following indication is requested to be added:
Laser periodontal:
Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eiel Ruth formxm
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic,
Division of Surgical, Devices Division of Surger------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Number K102359
Page 2 of 2