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

    ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM

    K Number: K121515 · Decision Jun 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    73
    Applicant Total
    8
    Review Days
    14

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    Basic Information

    Device Name
    ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
    K Number
    K121515
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solta Medical, Inc.
    Date Received
    May 22, 2012
    Decision Date
    June 5, 2012
    Product Code
    ONF
    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
    ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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