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

    PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)

    K Number: K853812 · Decision Nov 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    10
    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
    PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)
    K Number
    K853812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1630
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Biosan Laboratories, Inc.
    Date Received
    September 12, 1985
    Decision Date
    November 1, 1985
    Product Code
    HLX
    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
    HLX Photostimulator, Ac-Powered

    Similar 510(k) Clearances

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

    MODIFICATION TO EDI VERIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EDI VERIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CLARUS ENDOSCOPIC HOOK KNIFE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RETINA TESTER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SCOPTOPIC SENSITIVITY TEST-1[SST-1]

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IRAS EDS INTERFEROMETRIC STIMULATOR

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

    Other Clearances by Biosan Laboratories, Inc.

    K Number Device Name
    K860642 PHOTRON VISUAL FIELD ANALYZER
    K832763 TOBRAMYCIN REAGENT
    K833193 RADIOIMMUNOASSAY, THYROID STIMU. HORMONE
    K834023 BIO-SCIENCE LABORATORIES T4 REAGENT
    K833318 NORMAL GOAT SERUM
    K833192 NORMAL URINE CONTROL
    K833191 ABNORMAL URINE CONTROL
    K833320 AMBERLITE CG50 RESIN, 100-200 MESH
    K833319 BIO-REX 70 RESIN 100-200 MESH PH6.2