BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE

    K Number: K864610 · Decision Jun 18, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    3
    Review Days
    210

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    Basic Information

    Device Name
    CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE
    K Number
    K864610
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Inframed, Inc.
    Date Received
    November 20, 1986
    Decision Date
    June 18, 1987
    Product Code
    LLF
    Advisory Committee
    Unknown
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLF Laser, Neurosurgical, Argon

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    Other Clearances by Inframed, Inc.

    K Number Device Name
    K852761 CILAS MODEL YM101
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