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

    Catalys Precision Laser System

    K Number: K182083 · Decision Nov 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    46
    Applicant Total
    6
    Review Days
    99

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    Basic Information

    Device Name
    Catalys Precision Laser System
    K Number
    K182083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amo Manufacturing USA, LLC
    Date Received
    August 2, 2018
    Decision Date
    November 9, 2018
    Product Code
    OOE
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OOE Ophthalmic Femtosecond Laser

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    Other Clearances by Amo Manufacturing USA, LLC

    K Number Device Name
    K223838 Catalys™ Precision Laser System
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    K210701 CATALYS Precision Laser System
    K172002 Catalys Precision Laser System
    K141852 IFS ADVANCED FEMTOSECOND LASER SYSTEM