LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030810
    Device Name
    COOLAN 300
    Manufacturer
    COOLANALGESIA LTD.
    Date Cleared
    2004-05-05

    (419 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    COOLANALGESIA LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CoolAn 300 device is intended as a skin-cooling device used to minimize pain and thermal injury during laser and light-based dermatological treatments. Alternative uses include skin cooling as a local topical anesthetic for injections.
    Device Description
    CoolAn 300
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1