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510(k) Data Aggregation

    K Number
    K251254

    Validate with FDA (Live)

    Device Name
    Ignite RF System
    Manufacturer
    Date Cleared
    2026-01-15

    (267 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

    The Ignite RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.

    Morpheus8: At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Burst and Burst Deep Applicator is limited to Skin Types I-IV.

    Device Description

    The Ignite RF System is a computerized system generating RF energy for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis.

    The Ignite RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpieces are connected to the console via a cable and a foot switch activates the energy delivery to the handpiece. Multiple handpieces are available. The System is compatible with the following handpieces:

    • Monopolar ("RFAL") handpieces: These handpieces are comprised of a disposable, single use plastic handle with active internal electrodes and external (return) electrodes. Both internal and external temperature are constantly monitored.

    • Bipolar ("Quantum") handpieces: comprised of a disposable, single use plastic handle with active internal bipolar electrodes and no external electrodes. Control of the thermal effect is by selection of delivered amount of energy.

    • Morpheus8 Burst/Burst Deep handpieces: the Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The Morpheus8 Applicator comprises a handle and detachable, sterilized, disposable, single-use tip head accessories. Control of the thermal effect is by selection of delivered amount of energy.

    AI/ML Overview

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