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

    LASER AND EMPHASIS SCLEROSTOMY TIP

    K Number: K926470 · Decision Jul 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    5
    Review Days
    206

    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
    LASER AND EMPHASIS SCLEROSTOMY TIP
    K Number
    K926470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Summit Technology, Inc.
    Date Received
    December 28, 1992
    Decision Date
    July 22, 1993
    Product Code
    HQF
    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
    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 Summit Technology, Inc.

    K Number Device Name
    K980675 SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
    K915651 OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM
    K912522 OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER
    K904470 SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE