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

    MEDILAS 2 ND:YAG LASER SURGERY SYSTEM

    K Number: K855093 · Decision Feb 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    47
    Applicant Total
    24
    Review Days
    63

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    Basic Information

    Device Name
    MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
    K Number
    K855093
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Endo Lase, Inc.
    Date Received
    December 20, 1985
    Decision Date
    February 21, 1986
    Product Code
    HHR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HHR Laser, Surgical, Gynecologic

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    Other Clearances by Endo Lase, Inc.

    K Number Device Name
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    K853903 ENDO-LASE CD40 CO2 FOR GYNECOLOGY
    K853876 ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY
    K853877 ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY
    K853901 ENDO-LASE CD 40 FOR DERMATOLOGY
    K853580 MEDILAS 2
    K860152 MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY
    K853902 ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY
    K853875 ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY
    Search all 24 clearances from Endo Lase, Inc. →