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510(k) Data Aggregation

    K Number
    K253261

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-13

    (165 days)

    Product Code
    Regulation Number
    878.4400
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Q-LF handpiece, Q-FX handpiece, Q-SC handpiece, and Q-BT handpiece in RF mode are intended for:

    • Relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

    Q-EP handpiece in cooling mode is intended for:

    • Use in dermatologic procedures for the removal of benign lesions of the skin and for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
    Device Description

    Apollo Quattro is a combination stimulator used to relieve pain by applying radio frequency, low frequency, heating, and cooling energy to the affected area.

    Apollo Quattro has a Q-EP handpiece, Q-LF handpiece, Q-FX handpiece, Q-SC handpiece, Q-BT handpiece, patch (cleared under K042301), patch cable, funnel hose, and power cable.

    The Q-LF, Q-FX, Q-SC, and Q-BT handpieces are used for radio frequency or low frequency output, while the Q-EP handpiece is used for heating or cooling output, or for low frequency when used with the patch and patch cable.

    The cooling function of Apollo Quattro is substantially equivalent to the device cleared in K213294. The Apollo Quattro is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin.

    AI/ML Overview

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