LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K241358
    Device Name
    BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
    Manufacturer
    Sun Pharmaceutical Industries, Inc.
    Date Cleared
    2024-06-13

    (30 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170E is intended to provide phototherapeutic light to the body. The BLU-U Model 4170E is generally indicated to treat dermatological indications. The BLU-U® Model 4170E is specifically indicated to treat moderate inflammatory acne vulgaris.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement. The document is an FDA 510(k) clearance letter for a medical device, which confirms its substantial equivalence to a legally marketed predicate device. It discusses regulatory compliance and general information but does not include the specific technical performance study data you are asking for.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1