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

    QUASAR BLUE LIGHT THERAPY SYSTEM

    K Number: K093963 · Decision Aug 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    50
    Applicant Total
    5
    Review Days
    247

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    Basic Information

    Device Name
    QUASAR BLUE LIGHT THERAPY SYSTEM
    K Number
    K093963
    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
    Silver Bay, LLC
    Date Received
    December 23, 2009
    Decision Date
    August 27, 2010
    Product Code
    OLP
    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
    OLP Over-The-Counter Powered Light Based Laser For Acne

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    Other Clearances by Silver Bay, LLC

    K Number Device Name
    K112362 C100 WRINKLE REDUCTION DEVICE
    K111286 QUASAR CALYPSO
    K091467 BABY QUASAR
    K072767 QUASAR BLUE LIGHT THERAPY SYSTEM