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510(k) Data Aggregation

    K Number
    K240543
    Device Name
    Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
    Manufacturer
    Medency S.r.l.
    Date Cleared
    2024-10-24

    (240 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

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

    Rapido Medical Laser is generally indicated for use in incision, vaporization, ablation, cutting and hemostasis, or coagulation of soft tissue in General surgery, Gynecology, Neurosurgery, Endovascular coagulation (EVLT/EVLA), Urology, Podiatry and Orthopedics, Dermatology, Plastic surgery and Aesthetics, Otolaryngology (ENT) and Oral surgery.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification and an "Indications for Use" statement for a medical laser device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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