BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    HEINE OMEGA 500

    K Number: K123316 · Decision Feb 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    86
    Applicant Total
    7
    Review Days
    124

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HEINE OMEGA 500
    K Number
    K123316
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heine Optotechnik GmbH & Co. KG
    Date Received
    October 25, 2012
    Decision Date
    February 26, 2013
    Product Code
    HLI
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    HLI Ophthalmoscope, Ac-Powered

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HLI), ordered by most recent decision date.

    RTVue XR OCT Avanti with AngioVue Software

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EnFocus 2300, EnFocus 4400

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OCT-Camera

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CENTERVUE MACULAR INTEGRITY ASSESSMENT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AMICO DH-W35 OPHTHALMOSCOPE SERIES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Heine Optotechnik GmbH & Co. KG

    K Number Device Name
    K142486 HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
    K142837 HEINE SIGMA 250 & HEINE SIGMA 250 M2
    K131959 HEINE MINI 3000(R) OPHTHALMOSCOPE
    K131961 HEINE BETA 200(R) OPHTHALMOSCOPE
    K123587 HEINE MINI 3000 LED OPHTHALMOSCOPE
    K101892 HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-