BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE

    K Number: K033768 · Decision Feb 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    4
    Review Days
    76

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    Basic Information

    Device Name
    ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
    K Number
    K033768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Altus Medical, Inc.
    Date Received
    December 3, 2003
    Decision Date
    February 17, 2004
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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    Other Clearances by Altus Medical, Inc.

    K Number Device Name
    K023954 ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES
    K022226 ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS
    K014040 FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS