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

    DIPLOMAX

    K Number: K946054 · Decision Jul 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    21
    Review Days
    211

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    Basic Information

    Device Name
    DIPLOMAX
    K Number
    K946054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optical Micro Systems, Inc.
    Date Received
    December 12, 1994
    Decision Date
    July 11, 1995
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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    Other Clearances by Optical Micro Systems, Inc.

    K Number Device Name
    K950218 OMS SLIMLINE PHACO HANDPIECE
    K935223 OPHTHALMIC SURGICAL SYSTEM
    K935226 I/V POLE
    K935003 ELECTRIC I/V POLE OR EIVP2
    K870068 ASPIRATION REVERSAL CONTROL (ARC) MODULE
    K844373 O.M.S. ULTRA-PHACO
    K844448 OMS/GONVERS RETINAL PERFORATOR
    K844895 OMS SILICONE OIL INJECTOR
    K844467 OMS CRYO
    K844715 VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
    Search all 21 clearances from Optical Micro Systems, Inc. →