BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    NANOLAS ND:YAG OPHTHALMIC LASER

    K Number: K881459 · Decision Apr 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    11
    Review Days
    7

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    Basic Information

    Device Name
    NANOLAS ND:YAG OPHTHALMIC LASER
    K Number
    K881459
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Biophysic Medical, Inc.
    Date Received
    April 6, 1988
    Decision Date
    April 13, 1988
    Product Code
    LOI
    Advisory Committee
    Unknown
    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
    LOI Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

    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
    K883719 INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM
    K881494 FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER
    K873460 OPHTHALAS DYE OPHTHALMIC LASER
    K853116 PAXIAL
    K844686 OPHTHASCAN B
    Search all 11 clearances from Biophysic Medical, Inc. →