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510(k) Data Aggregation

    K Number
    K091125
    Device Name
    CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2
    Manufacturer
    VERILUX
    Date Cleared
    2010-09-03

    (504 days)

    Product Code
    ONE
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K080591
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERILUX

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

    The ClearWave Phototherapy System for Acne provides phototherapeutic blue light to treat mild to moderate inflammatory acne.

    Device Description

    The Clear Wave® Phototherapy System for Acne is a hand held light device which emits a low intensity of blue light at a wavelength of 414 ± 10 nm in the visible range of the spectrum. The head is programmed with a timed treatment cycle. The light modules are contained in the changeable head of a hand held device. The Clear Wave® Phototherapy System for Acne is small and light weight which allows for easy handling and mobility.

    AI/ML Overview

    This looks like a 510(k) submission for a phototherapy device for acne, not an AI/ML medical device. The provided text describes the device, its intended use, and substantial equivalence to a predicate device, focusing on electrical safety, biocompatibility, and usability testing. There is no mention of an algorithm or AI.

    Therefore, most of the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies is not applicable to this document.

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