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510(k) Data Aggregation

    K Number
    K190034
    Device Name
    REMY Medical Therapy Laser System
    Manufacturer
    Footdocprenur, LLC
    Date Cleared
    2019-05-15

    (128 days)

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

    REMY Medical Therapy Laser System

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

    The REMY device emits energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm: the temporary increase in local blood circulation; and the temporary relaxation of muscle.

    The REMY is intended for use in Podiation, vaporization, incision, and coagulation of soft tissue) including periungual, subungual, and plantar warts.

    The REMY is also indicated for use for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc., and for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc..

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the REMY Medical Therapy Laser System. This document is a regulatory communication and does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

    The letter confirms that the REMY Medical Therapy Laser System has been found substantially equivalent to pre-amendment devices or previously cleared predicate devices for its stated indications for use. This regulatory review primarily focuses on safety and effectiveness claims based on equivalence to existing devices, rather than requiring new clinical performance studies with specific acceptance criteria as might be seen for novel devices.

    Therefore, I cannot provide the requested information from the given text. The document does not describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method for a test set.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.
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