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

    MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL

    K Number: K791659 · Decision Oct 11, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    14
    Review Days
    50

    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
    MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL
    K Number
    K791659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Coburn Optical Ind., Inc.
    Date Received
    August 22, 1979
    Decision Date
    October 11, 1979
    Product Code
    HQF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQF Laser, Ophthalmic

    Similar 510(k) Clearances

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

    Voyager DSLT (430840610)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INTEGRE LIO

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Navilas Laser System 577sl (156691)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EyeQ nanoECP

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Leos Laser and Endoscopy System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LYNX Photocoagulator

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

    Other Clearances by Coburn Optical Ind., Inc.

    K Number Device Name
    K892351 MAGNILINK SYSTEM 602
    K892350 MAGNILINK SYSTEM 402/5
    K892349 MAGNILINK SYSTEM 209
    K892347 MAGNILINK SYSTEM 101
    K892348 MAGNILINK SYSTEM 201
    K862188 IRRIGATION & ASPIRATION/VITRECTOMY DEVICE
    K853457 COBURN I/A SYSTEM
    K821737 DISP. MICROSURGICAL KNIVES
    K812441 DI-CROWN
    K803159 AUTOMATED PERIMETERS
    Search all 14 clearances from Coburn Optical Ind., Inc. →