BEUDAMED
    Product Code: HJL FDA class 1 21 CFR 886.1380

    Lens, Condensing, Diagnostic

    Ophthalmic

    The Diagnostic Condensing Lens is an ophthalmic lens used with indirect ophthalmoscopes to condense light and create a wide-angle view of the retina and posterior segment of the eye for fundus examination. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is HJL, regulated under 21 CFR 886.1380, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.

    View on FDA
    510(k)s
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Unique Applicants
    1
    Years Active
    —

    Research product code HJL in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    HJL
    Device Class
    FDA class 1
    Regulation Number
    886.1380
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

    ✓
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K790526 LIO-714 OPACITYMETER

    FEI Numbers

    This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.