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510(k) Data Aggregation

    K Number
    K250852
    Device Name
    Coolfase
    Manufacturer
    ASTERASYS Co., Ltd.
    Date Cleared
    2025-10-16

    (209 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K170758
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Coolfase is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

    Device Description

    Coolfase is electrosurgical unit that high-frequency current for tissue coagulation during treatment. It consists of an electrosurgical unit main body, a handpiece, and a tip, and is used in conjunction with a grounding pad, coupling gel, and a foot switch. The high-frequency current generated by the main body is delivered to the skin through the handpiece connected to the tip. The electrical resistance of the skin generates heat, and this heat coagulates the tissue.

    AI/ML Overview

    N/A

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