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

    INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM

    K Number: K883719 · Decision Oct 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    11
    Review Days
    48

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    Basic Information

    Device Name
    INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM
    K Number
    K883719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Biophysic Medical, Inc.
    Date Received
    August 31, 1988
    Decision Date
    October 18, 1988
    Product Code
    LQJ
    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
    LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

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    Other Clearances by Biophysic Medical, Inc.

    K Number Device Name
    K953399 NEEDLE OR CUTTER
    K893035 OPHTHASCAN 'S' MINI-A
    K890509 INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM
    K884595 OPHTHASCAN MINI-B
    K884456 STERILE DISPOSABLE ENDOCULAR PROBE
    K881494 FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER
    K881459 NANOLAS ND:YAG OPHTHALMIC LASER
    K873460 OPHTHALAS DYE OPHTHALMIC LASER
    K853116 PAXIAL
    K844686 OPHTHASCAN B
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