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510(k) Data Aggregation

    K Number
    K012070
    Device Name
    ORALLITE COMPREHENSIVE EXAM TRAY
    Manufacturer
    TRYLON CORP.
    Date Cleared
    2001-11-27

    (148 days)

    Product Code
    MPU
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    MPU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OralLite Test Kit, when used in combination with conventional visual oral mucosal in The OralLite Test Kit, when used in other used in cardification, evaluation, and examination by nealth care providers, improved facilities in the reased risk for oral cancer.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the ViziLite™ Comprehensive Exam Tray and the OralLite Test Kit. However, it does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

    The letter primarily confirms that the devices are substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. The "Indications For Use" section for the OralLite Test Kit mentions its intended use in combination with conventional visual oral mucosal examination for improved facilities in "reased risk for oral cancer," but it does not provide any performance metrics or study details.

    Therefore, I cannot provide the requested information based on the provided text.

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    K Number
    K963391
    Device Name
    SPECULITE
    Manufacturer
    TRYLON CORP.
    Date Cleared
    1997-12-12

    (471 days)

    Product Code
    MPU
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    MPU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Speculoscopy is indicated for use in those women who are currently recommended for cervical screening with pelvic examination and Pap smear.
    • Speculoscopy is only to be used as an adjunct to the Pap smear, and only the combination of the two tests affords the clinician improved sensitivity in identifying women with mucosal abnormalities visualized on colposcopy.
    • The combined results of the Pap smear with Speculoscopy in the screening examination, designated Pap Plus Speculoscopy, can allow for the identification of more women who are appropriate referrals for colposcopy or close follow up than Pap smear alone.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Speculite®/Speculoscopy device and its Indications for Use statement. It does not contain information about acceptance criteria or a study proving that acceptance criteria were met. Therefore, I cannot fulfill the request.

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