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

    ULTRASUN 1000 & 2000 SUNTANNING UNIT

    K Number: K860932 · Decision Mar 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    14
    Review Days
    17

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    Basic Information

    Device Name
    ULTRASUN 1000 & 2000 SUNTANNING UNIT
    K Number
    K860932
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medical Device Consultants, Inc.
    Date Received
    March 11, 1986
    Decision Date
    March 28, 1986
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

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    Other Clearances by Medical Device Consultants, Inc.

    K Number Device Name
    K022895 ELCAM STOPCOCKS AND MANIFOLDS
    K002699 PARIETEX COMPOSITE (PCO) MESH
    K002116 S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
    K000551 IMAGE X-70 PLUS DENTAL X-RAY UNIT
    K974164 SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
    K864282 GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA
    K860122 HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
    K860929 ULTRASUN 4000 FT & 15000-8 SUNTANNING UNIT
    K860931 ULTRASUN 3000 AND 5000 SUNTANNING UNIT
    K860930 ULTRASUN 2500 SUNTANNING UNIT
    Search all 14 clearances from Medical Device Consultants, Inc. →