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

    ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY

    K Number: K853875 · Decision Jan 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    23
    Applicant Total
    24
    Review Days
    114

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    Basic Information

    Device Name
    ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY
    K Number
    K853875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Endo Lase, Inc.
    Date Received
    September 17, 1985
    Decision Date
    January 9, 1986
    Product Code
    EWG
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EWG Laser, Ent Microsurgical Carbon-Dioxide

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    Other Clearances by Endo Lase, Inc.

    K Number Device Name
    K853900 ENDO-LASE CD40 FOR NEUROSURGERY
    K853878 ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY
    K855093 MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
    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
    Search all 24 clearances from Endo Lase, Inc. →