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510(k) Data Aggregation

    K Number
    K982506
    Manufacturer
    Date Cleared
    1999-01-27

    (191 days)

    Product Code
    Regulation Number
    878.4350
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM

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

    1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratoses, achrochordon, molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, lentigo maligna, keratoacanthoma, basal cell, bowen's disease, lentigo discreta, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, kaposi's sarcoma, and pyogenic granuloma.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Verruca-Freeze Cryosurgery Delivery System™." It does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, or detailed ground truth methodologies for an AI/algorithm-driven device.

    The FDA 510(k) clearance process primarily establishes substantial equivalence of a new device to a legally marketed predicate device. While it may involve performance testing, the provided letter summarizes the administrative decision by the FDA, not the detailed study results.

    Therefore, I cannot extract the information you've asked for from this document. The document simply states the device is substantially equivalent for the indications for use listed, allowing it to be marketed.

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