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

    COMPAC(TM) DIODE LASERS

    K Number: K904699 · Decision Apr 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    18
    Review Days
    191

    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
    COMPAC(TM) DIODE LASERS
    K Number
    K904699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Hgm Medical Laser Systems, Inc.
    Date Received
    October 16, 1990
    Decision Date
    April 25, 1991
    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 Hgm Medical Laser Systems, Inc.

    K Number Device Name
    K921300 MODEL PC ARGON ION LASER
    K914484 LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE
    K913569 COMPAC A, ELITE A, ELITE A PLUS, SURGICA A
    K912628 AIR ARGON ION LASERS VARIOUS MODELS
    K910272 HGM COMBINATION ND:YAG & SOLID STATE GREEN
    K912438 MODELS 5,8,20,20S ARGON ION LASERS
    K910602 HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY
    K911104 PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1
    K910898 SURGICA(TM) H
    K904700 ENDOCOAGULATOR KRS568(TM) LASER
    Search all 18 clearances from Hgm Medical Laser Systems, Inc. →