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

    ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES

    K Number: K023954 · Decision Mar 18, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    4
    Review Days
    111

    Basic Information

    Device Name
    ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES
    K Number
    K023954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ALTUS MEDICAL, INC.
    Date Received
    November 27, 2002
    Decision Date
    March 18, 2003
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

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    Other Clearances by ALTUS MEDICAL, INC.

    K Number Device Name
    K033768 ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
    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