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510(k) Data Aggregation

    K Number
    K971216
    Device Name
    FRIGIDERM FRIGISPRAY
    Manufacturer
    DERMATOLOGIC LAB & SUPPLY, INC.
    Date Cleared
    1997-05-29

    (57 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K833446
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is intended to be used by Dermatologists and/or Plastic Surgeons for the following procedures. Freeze destruction on epithelial arising cryoresponsive benign, premalignant and malignant tumors, such as skin tags, verrucae, cutaneous horns, actinic keratoses, and basal cell carcinoma.

    Device Description

    The DELASCO Frigiderm FrigiSpray has engineered a 0.3L Vacuum Flask of stainless steel, brass and teflon for the dispensing of liquid nitrogen. The device assembly is also equipped with various size nozzles providing accessibility and a direct spray to different size lesions.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the Frigiderm FrigiSpray, a cryosurgical unit. It states that "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them.

    No performance data, and subsequently no acceptance criteria or study details regarding performance, are available in the provided text.

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